Skip to main content

Full text of "Lyme disease : a diagnostic and treatment dilemma : hearing before the Committee on Labor and Human Resources, United States Senate, One Hundred Third Congress, first session, on examining the adequacy of current diagnostic measures and research activities in the prevention and treatment of lyme disease, August 5, 1993"

See other formats


\ 



S. HRG. 103-265 

LYME DISEASE: A DIAGNOSTIC AND TREATMENT 

DILEMMA 

' 4.L 1 1/4: S. HRG. 103-265 — — = = 

Une Disease: A Diagnostic and Trea. .. 

HEARING 

OF THE 

COMMITTEE ON 

LABOR AND HUMAN RESOURCES 

UNITED STATES SENATE 

ONE HUNDRED THIRD CONGRESS 
FIRST SESSION 

ON 

EXAMINING THE ADEQUACY OF CURRENT DIAGNOSTIC MEASURES AND 
RESEARCH ACTMTffiS IN THE PREVENTION AND TREATMENT OF 
LYME DISEASE 

AUGUST 6, 1993 



Printed for the use of the Committee on Labor and Human Resources 




~C 



I? 



% 



U.S. GOVRItNMRNT PRINTING OFFICE 
73-299 CC WASHINGTON : 1993 

For sale by the U.S. Government Printing Office 
Superintendent of Documents, Congressional Sales Office, Washington, DC 20402 
ISBN 0-16-041765-1 



V 

S. HRG. 103-265 

LYME DISEASE: A DIAGNOSTIC AND TREATMENT 

DILEMMA 

.L 11/4:S. HRG. 103-265 

Disease: A Diagnostic and Trei. . . 



HEARING 

OP THE 

COMMITTEE ON 

LABOR AND HUMAN RESOURCES 

UNITED STATES SENATE 

ONE HUNDRED THIRD CONGRESS 
FIRST SESSION 

ON 

EXAMINING THE ADEQUACY OF CURRENT DIAGNOSTIC MEASURES AND 
RESEARCH ACTIVITDSS IN THE PREVENTION AND TREATMENT OF 
LYME DISEASE 



AUGUST 5, 1993 



Printed for the use of the Committee on Labor and Human Resources 
















U.S. GOVERNMENT PRINTING OFFICE 
73-299 CC WASHINGTON : 1993 



For sale by the U.S. Government Printing Office 
Superintendent of Documents, Congressional Sales Office, Washington, DC 20402 
ISBN 0-16-041765-1 



COMMITTEE ON LABOR AND HUMAN RESOURCES 
EDWARD M. KENNEDY, Massachusetts Chairman 
CLAIBORNE PELL, Rhode Island NANCY LANDON KASSEBAUM, Kansas 

HOWARD M. METZENBAUM, Ohio JAMES M. JEFFORDS, Vermont 

CHRISTOPHER J. DODD, Connecticut DAN COATS, Indiana 

PAUL SIMON, Illinois JUDD GREGG, New Hampshire 

TOM HARKIN Iowa STROM THURMOND, South Carolina 

BARBARA A. MIKULSKI, Maryland ORRIN G. HATCH, Utah 

JEFF BINGAMAN, New Mexico DAVE DURENBERGER, Minnesota 

PAUL D. WELLSTONE, Minnesota 
HARRIS WOFFORD, Pennsylvania 

NICK LlTrLEFIELD, Staff Director and Chief Counsel 
SUSAN K. HatTAN, Minority Staff Director 

(II) 



CONTENTS 



STATEMENTS 
Thursday, August 5, 1993 

Page 

Statements of diseased patients, family members, and other experts 2 

Keane-Myers, Andrea, recovered Lyme disease patient, Baltimore, MD: 
Ruchana White and son, Evan, Lvme disease victim, Suffern, NY; Carl 
Brenner, Lyme disease victim, Hawlcy, PA: and Karen Vanderhoof- 

Forschner, director, Lyme Disease Foundation, Tolland, CT 31 

Prepared statement of Ms. Forschner 45 

Durenbergcr, Hon. Dave, a U.S. Senator from the State of Minnesota, pre- 
pared statement 49 

Bradley, Hon. Bill, a U.S. Senator from the State of New Jersey 38 

Hochbrueckner, Hon. George, a Representative in Congress from the State 

of New York 53 

Burrascano, Joseph, Jr., M.D., East Hampton, NY; Kenneth B. Piatt, veteri- 
nary microbiologist, Iowa State University, Ames, IA; Matthew Cartter, 
M.D., epidemiology program coordinator, State of Connecticut, Hartford, 
CT, and Allen C. Steere, M.D., professor of medicine, New England Medical 

Center, Tufts University School of Medicine, Boston, MA 54 

Prepared statements of: 

Dr. Burrascano 57 

Mr. Piatt 61 

Dr. Cartter 65 

Dr. Steere 67 

McDade, Joseph, M.D., Associate Director of Laboratory Science. National 
Center for Infectious Diseases, Centers for Disease Control and Prevention, 
Atlanta, GA; and John R. LaMontagne, Director. Division of Microbiology 
and Infectious Diseases, National Institute of Allergy and Infectious Dis- 
eases, National Institutes of Health, Bethesda, MD 76 

Prepared statements of: 

Dr. McDade 82 

Mr. LaMontagne 88 

ADDITIONAL MATERIAL 

Articles, publications, etc.: 

List of various organizations and people with addresses who have sup- 
plied statements for tbe hearing record 95 

Responses to questions asked: 

Dr. McDade's responses to questions asked by Senators Dodd and 
Metzenbaum 86 

(ID) 



LYME DISEASE: A DIAGNOSTIC AND 
TREATMENT DILEMMA 



THURSDAY, AUGUST 5, 1993 

U.S. Senate, 
Committee on Labor and Human Resources, 

Washington, DC. 

The committee met, pursuant to notice, at 9:55 a.m., in room 
SD-430, Dirksen Senate Office Building, Senator Edward M. Ken- 
nedy (chairman of the committee) presiding. 

Present: Senators Kennedy, Metzenbaum, Dodd, Wellstone, 
Kassebaum, Thurmond, and Durenberger. 

Opening Statement of Senator Kennedy 

The Chairman. The committee will come to order. 

At the outset of the hearing, I want to express very sincere ap- 
preciation to the witnesses and to the families who are joining us 
here today. This hearing was scheduled a week ago and then, be- 
cause of the Senate schedule, it was necessary to reschedule it to 
today. So we are grateful to all of those who have made the special 
effort to come back again and be with us on this subject of enor- 
mous importance and significance from a public health point of 
view and most importantly from the point of view of the health 
needs of thousands of families, children, older people, all. 

So we are grateful to all of our witnesses and to the families who 
are so interested and concerned about this matter and whose inter- 
ests we want to pursue. 

Last week, we instructed the staff to conduct personal interviews 
with many of those who were here, and there is just a remarkable 
collection of stories, and we have communicated back to the par- 
ticular families and indicated that we wanted to make those part 
of the record. They will be made a part of today's record. It was 
an enormously valuable and useful exercise. 

I have in my hand and we have distributed the statements of the 
diseased patients, family members, and other experts, and it is 
really a remarkable collection of information and knowledge and 
will be very, very helpful to us on this committee, and I am person- 
ally grateful to all of those who spent the time to reveal some very 
difficult and painful experiences with us, and I am grateful to all 
of them for making it possible to include those comments as part 
of the record. 

[The prepared statements follow:] 

(l) 



STATEMENTS OF LYME DISEASE PATIENTS, FAMILY MEMBERS, AND 

EXPERTS 

As Reported to Staff Members op the Labor and Human Resources 

Committee 

Statement op Michele Aiello, R.N., 2326 Losee Ct., Merrick, NY usee 

Mrs. Aniello testified on behalf of her daughter, Beth, who has been infected with 
Lyme disease for 3 years. Mrs. Aniello is on the Board of Directors of the Long Is- 
land Lyme Association, one of the 20 Lyme disease support groups within the New 
York State Coalition of Lyme Disease, of which she is also a board member. 

In 1990, Beth Aniello came down with symptoms similar to those of meningitis. 
Since then she has seen at least 30 doctors, and she has been misdiagnosed with 
juvenile rheumatoid arthritis, lupus erythematosus, familial Mediterranean fever, 
osteomyelitis, and spondyloarthropathy. !•,««« 

Beth had suffered from multiple arthritis episodes when, in November of 1990, 
Mrs. Aniello read in a National Geographic article that Lyme disease can often be 
mistaken for other diseases. Beth's doctors took four tests for Lyme disease, all of 
which came back positive. However, the positive diagnosis was too late. 

Mrs. Aniello is a medical professional and has taken Beth to all the best doctors. 
When she was first diagnosed with Lyme, Beth was treated with Doxycycline for 
30 days. However, she relapsed repeatedly with arthritis episodes and bone and 
joint infections. In 1993, Beth was diagnosed with fibromyalgia, which is secondary 
to Lyme disease. Currently, she suffers from frequent fevers, sore throats, swollen 
glands, headaches, rashes, ringing in her ears, and muscle and joint pains. Beth 
misses school frequently, and occasionally, she must be tutored at home. 

Mrs. Aniello feels that doctors should be able to identify possible cases of Lyme 
disease right away when they see patients. This means that doctors in various areas 
of specialty should all be familiar with the symptoms of Lyme disease; thus, more 
education is needed for clinical recognition. 

Mrs. Aniello also claims that the tests for Lyme are unreliable, and that many 
produce false negatives as well as false positives. Further, there is currently no test 
that denotes cure. 

Statement of Linda Ardinger-Mateo 430 Simpson Place 

PEEKSKILL, NY 10566 (914)737-4331 

Mrs. Ardinger-Mateo has been infected with Lyme disease since 1981. That year, 
she suffered from back problems, and an orthopedic doctor prescribed exercises for 
her that turned her condition into severe sciatica. Over the next few years, all her 
muscles were tight, painful, and weak. The pain was often so great that it made 
her cry. She visitea many doctors and neurologists over the period, but did not re- 
ceive diagnosis or help. 

Gradually, Mrs. Ardinger-Mateo became more fatigued, and by 1987 she suffered 
from constant sore throats, headaches, severe fatigue, and some depression. Being 
a therapist herself, she thought her symptoms could be psychological, although her 
life was going well, and she could not imagine why she should be depressed A thera- 
pist she visited told her that she had no psychological problems. Another doctor test- 
ed her and diagnosed her with nonspecific hepatitis. She dropped her work hours, 
and after 6 weeks in bed the hepatitis had cleared up. 

She continued to see the same doctor over the next year as she suffered from the 
same flu-like symptoms. A Lyme test he gave her came back negative. Finally, he 
diagnosed her with Chronic Fatigue Syndrome and told her to find another doctor 
who could help her. 

Mrs. Ardinger-Mateo found a doctor who specialized in Chronic Fatigue Syn- 
drome, who put her on and off of ten-day doses of antibiotics. Although she felt bet- 
ter during these periods, she was told that her improvement was unrelated to the 
antibiotics because she had no bacterial infection. n 

At this point she began to suffer from neurological problems; she felt "zoned out , 
had difficulty understanding conversations, and had shortness of breath and heart 
palpitations. Her doctor then told her that she had hypoglycemia, even though her 
blood sugar tests were negative for the condition. 

After a year of constant health problems, Mrs. Ardinger-Mateo demanded that she 
be tested for Lyme, and the test was positive. Her doctor consulted Dr. Wormser, 
an expert at the New York Lyme Clime in Valhalla. Dr. Wormser instructed Mrs. 
Ardinger-Mateo's doctor not to treat her for Lyme because her Lyme titer was not 



high enough. However, her doctor decided to treat her anyway and put her on oral 
medication for 6 weeks, during which time her health declined and she was given 
additional tests. After her doctor switched her to 2 weeks on an IV, she felt some- 
what better. 

Mrs. Ardinger-Mateo's doctor discontinued treatment, and a year later she suf- 
fered from severe neurological problems. She had little balance, severe headaches, 
difficulty with reading and speech comprehension, dizziness, and trembling. A neu- 
rologist told her that she probably did not have Lyme disease, gave her more tests, 
and put her on the IV for 3 weeks. When she felt some improvement, she requested 
another week of IV but was denied due to the AMA protocol on the treatment. 

In 1989, Mrs. Ardinger-Mateo became too weak to work at all, and she discon- 
tinued her private psychotherapy practice and her work as a school social worker. 
She was bedridden and slept for 2 weeks straight, during which time her husband 
woke her to feed her. She felt abandoned by her doctor, who told her to wait 6 
weeks before any additional treatment. Although she had no history of psychological 

Eroblems, she began to suffer from panic attacks and clinical depression due to the 
yme germ. 

Mrs. Ardinger-Mateo consulted the Lyme disease support group and was referred 
to an internist who saw Lyme patients. She was diagnosed with late Lyme disease 
and for the next several months she was administered either oral medication or IV, 
with only slight improvement. 

Finally, she visited Dr. Burrascano, who has given Mrs. Ardinger-Mateo IV medi- 
cation for the past 2 years. She experienced significant improvement during the first 
year, with relapses when she was taken off the medication. She is now beginning 
to work again and do some socializing. She is starting to feel like a family member 
again. 

Mrs. Ardinger-Mateo has had difficulty receiving payment from her private dis- 
ability company, and was finally forced to accept a lump sum settlement which can- 
celed her policy. Her absence from work has had a serious impact on her family's 
finances, as she had previously earned 60 percent of the household income. Eventu- 
ally, her husband's union insurance was responsible for her coverage. However, the 
company refused to pay for what she was told was "willy-nilly treatment." 

Mrs. Ardinger-Mateo urges that legislation be passed to mandate that insurance 
companies pay for Lyme treatment as prescribed by the patient's doctor. She feels 
that there needs to be stricter enforcement for Disability Companies and Insurance 
Companies to honor their contracts, with penalties imposed on those companies who 
fail to honor them. 

She also urges that money be invested in research on curing late Lyme disease 
as well as early-detected cases. She claims that the so-called experts at Yale, New 
York Medical College, and Stonybrook are years behind the doctors that have been 
treating Lyme patients in their understanding of Lyme disease. Doctors with prac- 
tical experience with Lyme disease, as well as their patients, need to be heard. 

Statement of Janice T. Beers, J.D. 

268 N. Diamond Hill Road, Clayton, Ohio 45315 

Mrs. Beers strongly criticized the pamphlet published by Pfizer Central Research 
in 1990: "Lyme Disease: what it is — how it is transmitted — what it does to you — 
how to detect it — how to treat it — how to prevent it. The pamphlet was being dis- 
tributed to those in the room and was going to be given to Senators. It is outdated 
and contains misleading and incorrect information about Lyme disease. 

This is a complicated multisystemic bacterial disease. The symptoms listed in the 
pamphlet barely begin to describe the symptoms and combinations of symptoms that 
a patient with Lyme disease can present to a physician. The symptoms can go into 
remission and the patient cam present different combinations of symptoms from 
time to time. And different patients present differently, often very differently, de- 
pending upon what parts of the body are attacked by the bacteria at that time. 

The pamphlet says nothing about the overwhelming fatigue and malaise which 
usually are part of Lyme disease along with other symptoms such as eye symptoms. 
Nothing is said to indicate how devastating and debilitating and disabling the com- 
bined symptoms of disseminated Lyme disease can be. 

Mrs. Beers objected on page 1 to the statement that "It can start out as a skin 
rash and can progress through stages to arthritic, cardiac, or neurologic disease." 
The stages of Lyme disease have been abandoned and now the disease is described 
as localized (undisseminated) disease or disseminated disease. Statements that dis- 
seminated disease may have arthritic, cardiac, or neurologic symptoms are true, but 
the way they are here and in a myriad of other publications makes it appear, incor- 



rectly, that these are the only symptoms of disseminated disease. It is such state- 
ments that make the disease unrecognizable to the public and physicians alike. 

Mrs. Beers criticized the section "Later disease symptoms" on pages 9 to 11. Many 
patients seem to recover from early disease if treated fast enough and aggressively 
enough, but that is not made clear in the pamphlet. It is impossible to say that most 
patients do not develop later symptoms of Lyme disease; nobody knows, and enor- 
mous numbers develop such symptoms. Also, to say on page 9 that later symptoms 
"include complications of the heart, nervous system, or joints" reduces what happens 
in the late stage disease essentially to a triad of symptoms which misleads and 
which makes Lyme disease unrecognizable to the average person and physician. 

It is the emphasis on Lyme arthritis and on pictures of big swollen knees as on 
pages 10 and 11 that causes many to be unable to recognize that a person without 
these may have Lyme disease. Pain in the knees and multiple other joints does not 
have to be accompanied by swelling for a person to have Lyme disease, and not all 
Lyme disease patients have joint pain, at least not all the time. The only "heart 
symptoms" listed are dizziness, weakness, and an irregular heartbeat' nothing is 
said about heart palpitations or severe and serious heart complications. More nerv- 
ous system symptoms are listed, but nothing said about meningitis or stoke or other 
frightening and/or serious nervous system complications. 

Mrs. Beers criticized page 12 on treatment. It is badly out of date. It is true that 
Lyme disease is "treatable." But to say it can be "handled" fails to give the slightest 
clue to how difficult it can be to treat disseminated, entrenched disease. The pam- 
phlet does not disclose what tens of thousands of Lyme disease patients know from 
personal experience: frequently disseminated disease responds to some extent to 
antibiotics, but relapses occur with distressing frequency and for many the disease 
is intractable to present treatments, even long-term treatments with newer anti- 
biotics. 

Mrs. Beers' criticism is not limited to this pamphlet on Lyme Disease. The Cen- 
ters for Disease Control produced "Lyme Disease: a public information guide" which 
erroneously states that "Most patients who are treated in later stages of the disease 
also respond well to antibiotics, and full recovery is the rule." Full recovery is not 
the rule as those with disseminated disease can attest. The National Institutes of 
Health produced a pamphlet "Lyme Disease, The Facts, The Challenge" in 1992 
which also said that of patients with neurological symptoms, "Most experience full 
recovery." This is not true, either. There is no attempt here to point out all the defi- 
ciencies of these CDC and NIH publications. 

None of these three pamphlets describe Lyme disease so the multisystemic symp- 
toms and protean manifestations of disseminated Lyme disease are recognizable to 
the public or physicians. This is particularly unfortunate because Lyme disease is 
a clinical diagnosis and there are so many inaccuracies in the usual laboratory se- 
rology tests-as all three pamphlets point out. All three pamphlets fail to tell about 
the great difficulties in the treatment of disseminated disease, and they fail to tell 
that for many, Lyme disease is a disabling and intractable to treatment. 

The sum total tr information about Lyme disease symptoms, diagnosis and treat- 
ment that is going to the public and physicians alike is deplorable. 

A better pamphlet needs to be written with emphasis on symptoms, diagnosis, 
and treatment — that is, a pamphlet which describes Lyme disease symptoms so the 
disease is recognizable to the public and physicians and so the realities of treatment 
and the difficulties of treatment are accurately described. 

Statement of J. J. Burrascano, MD 
139 Spring Road, East Hampton, NY 11937 

RECOMMENDATIONS 

1. Require that more realistic reporting criteria be developed and be adopted by 
all states. 

2. Require states to report all cases of Lyme, even if it must include active case 
detection. 

3. Fund fully the Rocky Mountain Laboratory and support its research on better 
testing and studies on vaccine research and pathogenesis. 

4. If standardized protocols for diagnosis and treatment are to be developed, then 
they should be devised in conjunction with practicing physicians and exclude the 
current inner circle of biased individuals, many of whom have their own private 
agendas. 



5. Press for in-depth, multimsciplinary study of chronic Lyme, l»ifav» with an 
inpatient unit at NIH, but not under the direction of the arthritis branch (NIAMb), 
but under the branch designated to study infectious diseases. 

6 Prevent third party payers from arbitrarily cutting patients off from needed 
therapy, as prescribed by their own attending physicians, and not allow some un- 
seen clerk or consultant who never cared for the patient to make decisions of upmost 
importance to the patient's health and future. 

7. Investigate and curtail the secret connection between insurance companies and 
those so-called Lyme experts who oppose long-term therapy yet who are being paid 
by these same companies to perpetuate and publicize this view. 

8. Stop harrasment by individual State health departments of physicians who 
manage Lyme aggressively, and when these physicians' practices come under criti- 
cism, ensure that judgment is made by their clinical peers, experienced in the clun- 
eal management of this illness, and not by non practicing individuals of lesser expe- 
rience ana knowledge. ,,.,.. i i A i_ • 

9. Develop a forum for afflicted patients and their physicians to relate their expe- 
riences to the scientific community so research will be directed more appropriately. 

Statement of Evelyn Conklin 
sii Union Ave., Peekskill, NY loeee 

Evelyn Conklin is a practical nurse who has friends and neighbors suffering from 
Lyme Disease. Ms. Conklin came to the forum, in her words, "for the children. I 
also want to talk about insurance and treatment. We will be paying for Lyme Dis- 
ease for a long time unless we spend more time and energy on early treatment. If 
we catch the disease early, we can prevent many of the problems associated with 
the long-term illness." ^ . .. . , 

Ms. Conklin stated that Lyme Disease patients become completely isolated and 
affected children can not go to school. Ms. Conklin said, "I just think they all need 

Ms. Conklin also stated, "After hearing these stories, I dont want to get the dis- 
ease. I am single, I live alone and I don't know how I could manage if I got the 
disease. I have been to many support group meetings and I see what they go 
through." 

Statement of Keith Dama, b Mohingson Ct., Holmdel, NJ 07733 

Mr. Dama's son, Jonathan, first evidenced symptoms of Lyme disease in Septem- 
ber of 1991. He was unable to stand up and could not even lift his head due to the 
severe headaches he suffered. However, the first doctor that Mr. Dama took his son 
to see did not know what was wrong with the child and put him on medication for 
10 days. The medicine, however, only relieved the symptoms temporarily, and 2 
weeks later, Jonathan suffered these same symptoms again. He was put on 
Amoxycylin for another week, but once off the medication he became sick once more. 

By the third time, however, Amoxycylin had no effect. For 3 weeks, Jonathan 
could not even stand up. When they took him to the hospital, his doctor could find 
nothing wrong with him. The doctor suggested that Jonathan's ailment was psycho- 
logical and that he was faking sickness in order to get out of school. Jonathan, 
though, began to suffer from dementia. He began screaming in the middle of the 
night and said he was seeing things. When Mr. Dama and his wife called the doctor 
in the middle of the night, he told them that there was nothing to worry about, and 
when they requested more help, the doctor told them that he would not provide any- 
more help unless Jonathan first saw a psychiatrist. The Dama's then stopped taking 
Jonathan to this doctor and sought a second opinion. 

The second doctor diagnosed Jonathan's illness as Lyme Meningitis after Jona- 
than tested positive to a mild Lyme test. The doctor began Claforan treatment, 
among the best available. Within 3 days, Jonathan could sit up and within 5 days 
he could walk again. Jonathan remained on I.V. treatment for 6 weeks until most 
of the symptoms were relieved. Two weeks after I.V. treatment was stopped, he re- 
lapsed. The doctor tried oral antibiotics, but these were ineffective. Jonathan finally 
went back to the hospital to have an I.V. line surgically installed in his chest. 

This time it took 7 months, until September 10,1992, until the symptoms were 
relieved and the I.V. line was removed. This time the Damas thought that their son 
was cured, but 6 weeks later he relapsed. He tried all kinds of oral antibiotics for 
10 weekss, but Jonathan only got worse, and in January 1993 he developed Tachy- 
cardia, a life threatening heart disorder. He was given a heart exam, but the doctors 
could find no heart disease and concluded that the Tachycardia was a result of 



6 

Lyme disease. Jonathan had surgery again to install another I.V. line, and 2 months 
later the heart condition was resolved and his symptoms had improved, but he was 
still not well. 

The doctor then decided to try another medication. In order to do so, however, he 
had to stop all other medication for a few days to let Jonathan's system clear out. 
In those few days he had a severe relapse. In a gradual procession over 5 days, Jon- 
athan got worse and worse. By the fourth day ne became extremely tired, and by 
the fifth day, the headaches had returned and he was completely dehabilitated. 
After 2 weeks of the new medication, he was able to walk again, but had neuro- 
logical deficits. He lost the ability to do simple mathematical computations, even 
though he is a gifted math student studying algebra. He also began to mix up words 
and letters ana lost his ability to concentrate. His severe headaches also remained. 
It has taken until now for his mental faculties to improve, and ho remains on I.V. 
therapy. 

Jonathan's treatment costs are roughly $2,500 per week, and until this year, the 
Damas' medical insurance has covered the charge. Their insurance companies, how- 
ever, have not yet agreed to cover the 1993 medical bills. 

Statement of William J. Didonato 

4425th Street, Atco, NJ oboo4, phone: (609) 767-oois 

Mr. DiDonato is the father, brother-in-law, and friend of patients with Lyme Dis- 
ease and he is also the coordinator of a Lyme Disease support group. 

Mr. DiDonato is concerned with the lack of understanding by some educators as 
to the complications and neurological effects of the disease. Some of its effects on 
the ability of young people in school are test-taking problems, memory loss, head- 
ache, lack of concentration. 

Mr. DiDonato said, "My daughter has been evaluated by a child study team be- 
cause she had to have home-study tutoring due to Lyme Disease. It has been con- 
cluded that she has a learning impairment that may or may not affect her for the 
rest of her life. Another major concern of mine is that there is no pharmaceutical 
company in the United States that has developed an intravenous antibiotic for treat- 
ment of Lyme Disease." 

Mr. DiDonato also said, Tm very fortunate to be employed with Philadelphia 
Electric Company whose excellent benefits make it possible for my daughter's treat- 
ment. The total cost of treatment since was first diagnosed twenty months ago has 
exceeded $30,000. My insurance company disputes the treatment prescribed by our 
doctor. In addition after all the money that has been spent on my daughter, her con- 
dition is only 25 percent improved." 

Mr. DiDonato stated, "I feel that the Centers for Disease Control and the National 
Institute? for Health are doing an injustice to all Lyme patients by not accepting 
the on-the-job diagnosis and first hand experience of those stricken with the disease. 
I would hope that the real life experiences and physical data from doctors in the 
field would be included in CDC and NIH criteria for dealing with the disease. We 
need a concerted effort to find a cure." 

Mr. DiDonato concluded, "I have brought with me today a petition signed by 
twenty-two other concerned citizens and would like it entered into the record." 

Statement op Beverly G. Dyer 

1863 Kalorama Road, Washington, DC. 20009 

I was bitten by a tick in June of 1989 — not hiking in the woods — but at a Yale 
Law School graduation party, in a fellow student's back yard. I developed a rash, 
but a dermatologist was unable to diagnose Lyme disease or any other basis for the 
rash. After 6 months, I began experiencing severe joint pains, wooziness, fatigue, 
and pain behind the eyes. 

I visited at least seven doctors, including a neurologist and a rheumatologist. I 
discussed the possibility of Lyme Disease with each of them, but the each said un- 
equivocally that I did not have Lyme Disease. None of them knew what was wrong, 
nor were they particularly concerned. One doctor laughed at me when I suggested 
trying antibiotic treatment to see if it would help. One doctor refused to listen to 
my symptoms, immediately diagnosed anxiety and depression, and prescribed 
Prozac. I was ready to give up on the medical profession. 

Eventually, through a string of references, I went to see Dr. Joseph Burrascano. 
I travel hundreds of miles to visit him every month or two. This is not unusual, 
in fact, most of the Lyme Disease patients I know of in the DC. area travel hun- 



dreds of miles for treatment — none have found a doctor here with expertise in long- 
term treatment. One doctor in northern Virginia is treating several patients, hut his 
patients know more than he does, and are telling him what to do. 

Despite more than a year of treatment, my symptoms have only marginally im- 
provedV although, when I have stopped taking antibiotics my have symptoms wors- 
ened. The only time my symptoms improved was following my first 7 week course 
of IV treatment. I still experience joint and muscle pain, woozmess, loss of balance, 
numbness in the right side of the body, fatigue, ana pain and pressure in the eyes, 
amongst many other symptoms. Overall, I often feel like I have been run over by 
a truck. 

Lyme disease has had a serious impact on my life. I can only work half time in 
my job as a lawyer, and have cut back on almost all family and social activities. 
At times, I have difficulty walking due to stiffness, and find it hard to be out of 
bed for more than a few hours a day. Sometimes the pain and pressure in my eyes 
makes it difficult to drive, read, or even watch T.V. The disease has also had a fi- 
nancial impact: I am on naif salary, my long-term disability insurer has not yet 
agreed that I am partially disabled, and I incur between five and ten thousand dol- 
lars in uncovered annual health expenses. 

I am only willing to describe my private, personal medical history on the record 
because of my growing frustration at the failure of the CDC and Nffl to acknowl- 
edge the serious public health threat of this disease, and because I believe patients 
canlcontribute to educating the Senate and the public. Virtually every Lvme disease 

Satient with whom I have spoken visited between five and ten doctors before being 
iagnosed, and received dismissive and condescending treatment by many of those 
doctors. Virtually every patient I have spoken with is still suffering from 
dehabilitating symptoms, despite treatment, some after years of treatment. Out of 
their difficult experiences, patients have developed a strong voice, through national 
patient networks formed to trade information and expertise. In addition, no one but 
patients can describe the scope and severity of the symptoms of the disease. I have 
spoken with patients who have suffered strokes, paralysis and loss of sight. 

I believe the reason that doctors (with the exception of a handful of dedicated 
practitioners, such as Dr. Burrascano) have largely been dismissive of patients' is 
due to the lack of reliable diagnostic tests, and to the fact that doctors cannot inde- 
pendently or objectively confirm patients' dehabilitating but mostly invisible symp- 
toms. Faced with uncertainty ana the extremely difficult problems of diagnosis and 
treatment of Lyme Disease, many doctors have jumped to premature conclusions. 
For example, Dr. Allen Steere has concluded that many patients do not have Lyme 
Disease, but his results — in which patients with active Lyme Disease have positive 
blood tests, while those who never had Lyme have negative blood tests — are inher- 
ently inconsistent with his own acknowledgement that the blood tests are unreli- 
able. 

Patients are desperate for more support from the CDC and Nffl for research into 
diagnosis and treatment, particularly into developing better diagnostic tests for the 
disease, discovering how the bacteria spreads through the body, reproduces, under- 
goes chemical changes, and cause the numerous and varied symptoms, as well as 
into finding both a human vaccine and antibiotics that can have more of an impact 
on curing the disease. 

More immediately, national organizations should improve the collection of data in 
the incidence of the disease, and on the frequency, severity, and progression of the 
various symptoms. That data could assist doctors in their difficult task of clinical 
diagnosis. In addition, the CDC should establish a more flexible range of criteria 
for reporting the diseases that permits reporting of definite, probable, and possible 
cases of Lyme Disease. Finally, the CDC, Nffl, and the AMA should work toward 
educating more doctors around the country in what is currently known about diag- 
nosis ana treatment. I implore the Senate to spur the CDC and Nffl into more ag- 
gressive action. 

Statement of Ann Ebert, 20 Beacon Drive, Howell, NJ 07731 

Mrs. Ebert is afflicted with Lyme Disease and confined to a wheelchair. She has 
three afflicted children, two of whom are in remission. 

She holds physicians responsible for this tragedy, claiming that their twenty-8 
day therapy does not work. The CDC is avoiding the facts, and lives are being lost; 
when will something be done, she asks? The establishment is putting its head in 
the sand by denying Medicare patients intravenous treatment for Lyme. Mrs. Ebert 
demands the government put more money into Lyme research, because, unlike 
AIDS, Lyme is not a disease of choice — it can victimize anyone. Early treatment can 
be effective in putting the bacteria in remission so their victims can resume their 



8 

roles as working members of society. Unfortunately, these people are forced to be 
shut up in closets because the government avoids addressing the problem. 

Mrs. Ebert demands Medicare extension to intravenous treatment. The problem 
must be addressed now, not 10 yean from now. 

Ann Ebert represents a group called New Jersey Voice, which proposed State leg- 
islation with an ultimate goal of national legislation. 

STATEMENT OP MAKYLOU EISENHARDT ON BEHALF OF HER 
HUSBAND MARTIN EISENHARDT 

This letter is written on behalf of my husband, Martin Eisenhardt, who died as 
a result of Lyme disease on July 3,1993. He bravely fought an 8 year battle with 
that disease and all that it did to him. 

His symptoms became medically evident March 1986. Hospitalization was nec- 
essary due to the severity of his physical symptoms many, many times during those 
8 years. The first year of his illness he was hospitalized in March and after spend- 
ing time in two more hospitals he was released in mid April of that year and was 
diagnosed with nothing more than aseptic meningitis. Continued, serious symptoms 
prevailed and worsened as days went by. Weekly trips to a series of doctors were 
necessary to treat the variety of symptoms. He was hospitalized twice again in June 
and was transferred to Massachusetts General Hospital where for 96 days he suf- 
fered from loss of speech and inability to eat or move. He was transferred again to 
Albany, NY, all the time a "puzzle to the medical profession. A shell of a once 
healthy person was finally sent home without a diagnosis. 

Since he was a puzzle to the medical profession, I, his wife was told to put him 
in a nursing home and forget him. I chose not to follow the decree of the medical 
profession. I wanted him to find freedom at home. Unfortunately, because of his 
prognosis, no doctors would even come to our home to treat the severe symptoms 
which remained to plague his body. 

My quest to find out what had caused this complete dehabilitation and deteriora- 
tion of a "perfectly healthy^ man, as he was evaluated by our family doctor in Feb- 
ruary of that year, led me on an unbelievable journey. 

My husband had the classic symptoms of Lyme disease and although we asked 
doctors to look into that possibility, our pleas were ignored or dismissed. Watching 
an episode of "20/20" in 1988 led me to having an Elina test for Lyme disease at 
Stonybrook, NY. Results were positive even 3 years into the horror. 

Medical help came only upon my insistence. He was given fourteen days of treat- 
ment of Rocephin by IM not IV. The neurological damage that had occurred prior 
to that antibiotic treatment needed much more help than that, but their answer was 
no and the death verdict continued. Martin did respond to antibiotic treatment, but 
unfortunately, antibiotics were only given for his pneumonia bouts and not for Lyme 
treatment. As soon as the various pneumonias cleared the antibiotics were stopped. 
The sad cycle would continue. 

My husband had been diagnosed with severe Lyme disease based on a variety of 
tests done in 1992 — and also upon his autopsy which I insisted was necessary to 

{>rove his cause of death. A brilliant, healthy man was wasted by lack of treatment 
or Lyme disease. Our lives and family were devastated by this event. The economic 
impact on our lives was also devastating. 

Living with the horror of Lyme disease ignorance has led me to meet many poor, 
suffering people across America. These people need help desperately from a better 
informed medical community and proper recognition of this devious, dangerous, and 
devastating illness that is very real to all who suffer from its variety of symptoms. 
Do not ignore our plea for real treatment and research. 

Statement of Karen Fordyce, 16 Bates Rd, Jackson, NJ os627 

"My son and I— My son was 9 at the time— got sick in 1987. We hiked together 
with our dog for relaxation, through woods that have been shown to be one of the 
most infected in New Jersey. Of course, at that time, there was no education. I 
knew two things, that there was a bullseye, and that you treat it with antibiotics. 
And I believed it." 

"I think we must have been infected at that time. Our symptoms were constant 
headaches, fatigue, pain. I had put myself through college with two kids, and come 
out with a 4.0, an accomplishment I take pride in. My education had gotten me a 
job as a systems analyst at a major insurance company. But I started to have trou- 
ble doing my job. I started to get tired, have headaches, and have mood swings. I 
kept getting bronchitis. So theyd put me on antibiotics for that. Td feel better, but 



9 

then it would all come back after I stopped anti-biotics. It got worse and worse. My 
son developed swollen lymph nodes. His lymph nodes were huge, he was fatigued, 
he was getting thin, he had dark circles under his eyes. He was literally wasting 
away." 

"We went from doctor to doctor to doctor. I was told I was suffering from allergies 
or stress. I was told to seek psychiatric help. They told me that my son looked sick, 
but that they weren't able to confirm a diagnosis. 

'Tinally, in 1989 I read about Lyme, ana I went to a doctor and asked for a blood 
teat. I was positive. I was also lucky. I found a physician who was open to chronic 
Lyme and would treat me and my son. We went on orals, and we improved, but 
our condition deteriorated when we stopped. Finally, we went on 6 weeks of IV. And 
we got much better. Much better. We really improved." 

"But my son relapsed this year. Even before the relapse, school was very difficult, 
because of short-term memory problems and attention deficiencies. After his relapse, 
his grades fell even more and he's been in and out of school all year. He's on orals, 
but who knows how long we can keep this up. He's been listed as chronic by the 
school system. I don't know what the future is for him." 

"I went downhill as well. Over the last 4 years, I have been on I.V. 3 times and 
on orals in between. I've been on disability from my job for 3 years. I'm now 
dyslexic, I have brain lesions and attention deficits. Fm in constant pain. I often 
don't sleep until 4 in the morning. My son can't sleep either and that s one reason 
he's having trouble in school. I feel very strongly that there isn't a cure for this dis- 
ease once it's in the central nervous system. We're still shedding the DNA of the 
spirochete 4 years after treatment started." 

"I have another child, a 19 year old in school in Colorado. She is a biology major 
and teaches Aerobics. But recently she started complaining about not being able to 
remember things, about her feet hurting. We tested her and she's positive. I have 
two children with it now, and I don't know what's in store for them. I fear for my 
children. We've got to give help to our children." 

"We need the CDC to recognize chronic Lyme disease. I know I won't be able to 
get coverage for IV if I try, because I fall outside the CDC definition for Lyme dis- 
ease. I should be able to get insurance coverage if my doctor says I have Lyme. I 
have worked to educate people at the grass-roots level about this disease: We now 
need to educate the CDC and the NIH. 

"I wish the NIH would talk to patients, to discover that we need funding for 
chronic Lyme. Lyme funding mainly goes to short-term research. Our small group 
funds Dr. Manifred at Bayer, Fox-Chase cancer center in Philadelphia. We give him 
$20,000 a year. Do you know what it takes for a small group like us to raise that 
much? And he's done research that the NIH and the CDC can use. I know other 
good researchers that the NIH wouldn't fund." 

1 would finally like to emphasis that we are not crazy. We are bright, articulate 
people stricken with a terrible disease. We deserve to be heard, we deserve to be 
recognized, and we deserve action on our behalf." 

Statement of Marc Gabriel 

1050 Lawrence Avenue, Westfield, NJ 07090-3721 

During the summer of 1990, 1 worked at the local office of the Bureau of the Cen- 
sus in Mountainside, NJ. The office building was located a few hundred feet from 
the Watchung Reserve, an area endemic for Lyme disease. We often are lunch out- 
side. 

When I returned to Lehigh University in the fall as a sophomore electrical and 
computer engineering student, I developed the following symptoms: 

migratory Toot and leg pains; temporary bouts of peripheral paralysis; headaches; 
extreme fatigue; and inability to concentrate. 

After speaking to many people, I was told that my problem was stress. I was re- 
ferred to the counseling service. 

By the spring of 1991, I became convinced that the problem was not in my head 
but rather a medical one. I visited my primary physician at the HD? Rutgers HMO 
in New Jersey. He sent me to a specialist for each symptom. After several months 
of fruitless investigations, we came to a dead end. No one could figure out what was 
wrong, and I was degenerating rapidly, the migratory pains had turned into arthri- 
tis and the fatigue and headaches became much more serious. 

In the late summer of 1991, an orthopedist friend of the family invited me in for 
a consultation. After 3 visits, he recommended that I have a Lyme titer performed. 
He mentioned that he had seen many bizarre" cases of joint pain recently in West- 
field, and they turned out to be Lyme disease. 



10 

HIP Rutgers performed an ELISA that was borderline, and then a second that 
was negative (on the Robert Wood Johnson scale). I read-up about Lyme disease and 
learned that a negative test does not rule out the disease, but my doctor did. He 
told me "Lyme disease is overdiagnosed" and sent me home. 

We spent the next 9 months arguing back and forth. I met some of the most mis- 
informed doctors in my life during this experience, they were spitting out garbage 
that I contradicted with medical references. They just didn't care. 

In the spring of 1992, my condition worsened and I had to drop most of my 
courses. After a dramatic encounter with a clueless HEP Rutgers infectious disease 
specialist, we went to the SUNY Stony Brook Lyme Disease Clinic, where Drs. Ben- 
jamin Luft and Raymond Dattwyler diagnosed me with Lyme disease. 

They prescribed 3 weeks of IV Rocephin via HIP rutgers. My condition improved, 
but I relapsed after the treatment ended. I then demanded additional treatment. 
After the initial resistance, they conceded (probably because they were afraid I 
would slap them with a malpractice suit). I relapsed again after the additional 3 
weeks. I left the HMO and sought the help of a Lyme specialist. 

While my neurological symptoms are fully under control with the help of the spe- 
cialist, I have sharp joint pain. To control this, I use: 

Oral antibiotics; Non Steroidical Anti-Inflammatory Drugs (NSAIDs); Hot water 
therapy every morning; A TENs unit; and Frequent rest. 

I am 21 year old, and I may have chronic arthritic pain for the rest of my life 
because I had stubborn doctors who didn't have a clue what they were doing. All 
they knew was "Lyme disease is overdiagnosed." They sounded like parrots. 

I wish I could say that my case is rare. Unfortunately, it is not. The INSTITU- 
TIONAL DENIAL IS ENTRENCHED. Doctors refuse to believe Lyme disease is a 
problem UNTIL A LOVED ONE IS HIT BY IT. Them, they believe. 

STATEMENT OP BARBARA GOLDKLANG 

Lyme disease has attacked Barbara's family with a vengeance. Not only does she 
have the debilitating disease, but her two daughters also have been stricken with 
Lyme. Her older daughter, a good student, was forced to give up a medical career, 
daunted by the physical and mental strain of medical school. Debilitating fatigue 
caused Barbara to give up her antique interior decorating business to handle fewer 
clients from her home. Unable to concentrate and focus her thoughts, she eventually 
had to abandon her work altogether. Once an accomplished cook, Lyme has left her 
unable to follow a recipe. 

Barbara underwent psycho-neuro testing at a Yale clinic where she was diagnosed 
with "deficits consistent with Lyme disease." Testers stated that active infection 
could not be ruled out and recommended trail antibody treatment although Barbara 
would not be diagnosed with Lyme if tested by the standards that Dr. Steere advo- 
cates. 

Barbara received IV treatments for her illness. The first treatment had little ef- 
fect. She responded well to the second treatment. However, she later relapsed and 
serious cognitive problems returned. The third treatment was successful, and Bar- 
bara recovered partially. While she still is unable to concentrate for an extended pe- 
riod of time, her cognitive problems are less severe than previously. Speaking with 
Barbara, one notices that she lapses between phases of extreme coherence ana intel- 
ligence, utilizing a broad vocabulary and demonstrating her high intelligence, and 
phases of inattentiveness and inability to concentrate. 

Barbara advocates: 

that chronic persistent infection be addressed and researched by NIH; and the es- 
tablishment of a children's facility to research the treatment of adolescents and 
young adults infected with the Lyme virus. 

Barbara feels that the disease has been largely dismissed by academia (private 
university researchers) and this is a chief reason that Lyme disease has not been 
properly studied. 

Statement of Judi Hason 

34 glldare drive, east nohthport, ny 11731 

Judi Hason is on the Board of Directors of the Long Island Arthritis Foundation 
and is also the Chairperson of Education of the Lyme Disease Coalition of New York 
State. 

Her statement is as follows: 

The Lyme Disease Coalition represents 25 support groups in New York State. We 
have thousands of people belonging to our coalition that are sick with Lyme Disease 



11 

and are not getting better. If Lyme Disease is a an easily curable disease, why do 
we need 25 support groups in New York State? 

We only represent one State in this country. There are hundreds of support 
groups in all across the country. We need money for research to help all those suf- 
fering from this disease." 

Ms. Hason has been sick with Lyme Disease for 4 years. She has been treated 
twice with intravenous antibiotics, and still is not 100 percent well. She suffers from 
severe arthritis and was forced to close her business and end her career as a free- 
lance jewelry designer. 

Accompanying Ms. Hason was Ms. Karen Gustafson, a co-facilitator of the Long 
Island Arthritis Foundation and a strong supporter of the New York State Lyme 
Disease Coalition. Ms. Gustafson has tested both positive and negative for Lyme 
Disease and has suffered from arthritis and vertigo in the past few years which she 
attributes to the disease. 

Statement of Ray Hernandes 

ioi West Main Street, Clinton, NY 08809 

Mr. Hernandez believes that a grassroots education is the most important element 
in combating Lyme disease. Specifically, a thorough education that begins in Kin- 
dergarten is needed to make children aware of the symptoms of Lyme disease and 
the means to prevent it. 

Mr. Hernandez believes that doctors are also misinformed about the disease. He 
believes that: 

Doctors are not familiar with the symptoms; Doctors are not familiar with effec- 
tive treatment programs; and as a result doctors tend to mistreat Lyme diseases as 
if it were another malady. 

Mr. Hernandez would encourage rigorous education to doctors. Information should 
be published and distributed to physicians and medical forums should be held to 
disseminate information about the disease and its treatment. 

One other major problem that Mr. Hernandez cited was that doctors are not al- 
lowed to freely treat patients due to restrictions imposed by insurance companies. 
These powerful insurance companies are readily willing to treat cancer patients, for 
example, but will not treat those inflicted with Lyme. In the long-run, according to 
Mr. Hernandes, this will actually cost the insurance agencies more money due to 
lawsuits and other legal fees. 

Mr. Hernandez then described his own affliction with Lyme disease, stating that 
it was a typical case of doctor misdiagnosis and mistreatment. When Mr. Hernandez 
first noticed the symptoms and rash typical of a Lyme tick bite, his personal physi- 
cian told him to "throw the tick away^ because the chances that he had Lyme dis- 
ease was one in a million". Subsequent diagnoses and opinions included gout, stress, 
and depression. Only after seven doctors, cud one ask for a medical history involving 
any peculiar bites or rashes. 

By the time this doctor concluded that Mr. Hernandez might be afflicted with 
Lyme disease, he had already lost his job in construction due to a loss of equi- 
librium, slurred speech and impaired vision. Mr. Hernandez claimed that Lyme dis- 
ease is not taken seriously enough as a affliction. Considering that it is second only 
to the AIDS in the number of infections, the United States should be doing much 
more than it currently is to educate the public as to the dangers of the disease. 

Statement of Martha Kramer 

Nebsox Lane, Garrison, NY 10524, 014) 424-4051 

Martha Kramer's family is chronically ill with Lyme disease — her husband, her 
9 year old son and herself. She has two other children who remain in a healthy con- 
dition so far. Her family has spent 3 years on antibiotics to halt the progress and 
control the symptoms of the disease. In fact, her son has never known a disease- 
free life. She complains that there is too little research funding for those who are 
chronically ill, which should be committed to by the government. 

She explains that her family is not an isolated case. In the township of 
Phillipstown, New York, many families have a similar experience in which they 
must live under the fear of an endemic community. Mothers and fathers are sick 
with the disease, their livelihood is jeopardized, and their children are invariably 
missing school. 

Those who missed an early diagnosis are having to fight for treatment. Many in- 
surance companies are denying benefits because long-term antibiotic treatment is 



12 

considered "unsubstantiated and experimental." She says antibiotics are the only 
life line until research finds a cure, which should be made the absolute priority. 

She also mentions the dysfunction of the health care system — her own insurance 
company overcharges which gets her family in trouble financially. When the dan- 
gerous bacteria iniects her children's brains, and makes them weaker day by day, 
she cannot turn down payments for their health. 

Statement of Carol Laymon, 604*th Avenue, East Northport, NY 11731 

"If it's not as severe as they're saying, why are there 25 support groups and two 
coalitions-New York and New Jersey-which don't have the funding to help? Fund- 
raising has been done, but it is very difficult.'' 

One May morning in 1986, Carol Laymon awoke to find three new beauty marks 
on her body. After examining them closely, she found that they were caused by tiny 
deer ticks. In the days that followed, Carol began to feel fatigued almost daily. 
Movement became painful, and she developed a persistent earache and extreme 
neck pain. 

Specialists were no help to Carol. After 4 weeks she experienced a major breakout 
of symptoms including neck and back pain and extreme dizziness. 

As her illness continued, Carol was demoted from District Manager of the 1st 
Federal Savings and Loan to manager. 

She underwent "thousands" of tests including nerve tests, CTs, and MRrs. She 
saw ten doctors, and all of her tests came back negative. All the while she felt sicker 
and weaker. Her muscles were weakening; her knees were troubling her; she had 
sever headaches and rashes. Her symptoms became so severe that she was no 
longer able to drive. She once lost consciousness while driving. Her illness also ren- 
dered her unable to do her job, and as a result, she had to quit. 

She saw twenty doctors; each ignored her rash. In 1990 she felt psychosomatic 
and saw analysts for the next 10 months. Her family life was also adversely affected 
by her disease. Her three children and her husband of 7 years did not understand 
her disorder. The Laymons were forced to take a second mortgage on their home 
and use their savings to pay for Carol's medical bills. 

Carol took IV treatments for Lyme disease for 6 months in 1990. The treatments 
affected her entire body, relieving some of her symptoms. 

As a result of her sickness, Carol has peripheral nerve damage and muscle dam- 
age. She feels alternating periods of pain ana numbness in her face and hands. She 
feels that her nervous disorder is getting progressively worse. 

Carol is concerned that doctors are afraid to treat Lyme patients because of the 
threat of malpractice suits that could be brought in many Lyme cases. Doctors are 
also unaware of how to recognize and treat Lyme, primarily because it mimics 'so 
many other diseases. 

Statement of Anthony L. Lionetti, MD 

630 South White Horse Pike, Suite Ai, Hammonton, NJ 08037-2014 

I'm a physician, licensed to practice medicine in the states of New York and New 
Jersey. I'm specializing in internal medicine and over the past year alone have eval- 
uated over 500 people for the possible diagnosis and management of Lyme Disease 
(LD). I have felt compelled to share with this Committee some of my experiences 
and observations. Currently, in my private practice, I am involved in as a clinical 
investigator with the University 01 Pennsylvania in an NIH funded study of a new 
test for the diagnosis of LD called the Polymerase Chain Reaction (PCR) test. 

I have been trained in internal medicine residencies affiliated with New York Uni- 
versity and also with the University of Medicine and Dentistry of New Jersey. I 
must admit that residency training in this country is deficient in preparing the phy- 
sician to go out and diagnose LD. 

I have seen numerous patients with various manifestations of polyarthritis, head- 
aches, fatigue, and focal neurological deficits that have been given other diagnoses 
such as rheumatoroid arthritis, systemic lupus, arithmatosis, chronic fatigue syn- 
drome, and fibromyalgia to name a few, who were in fact really suffering from LD. 
These patients came to my office with reams of medical data from their personal 
files consisting of diagnostic laboratory testing, imaging studies, and specialty con- 
sultations from University physicians. What has been most disturbing to me in my 
review of these files has been the inappropriate usage and interpretation of the di- 
agnostic laboratory tests clinically available to aid in the diagnosis of LD. 

There have been patients who have had negative Lyme EL1SA tests who had de- 
scribed Erythema Chonicum Migrans (ECM) rashes after a tick bite followed by flu- 



13 

like symptoms than associated with polyarthritis, fatigue, and neurological symp- 
toms who were told that they did not have LD. In many of these cases a Lyme Dis- 
ease Western Blot was never performed. After obtaining a western blot from our of- 
fice they were found to have multiple bands present for LD which would be consid- 
ered positive by even the most stringent criteria for the western blot test. Of great 
importance has been that these patients have resolved their disease symptoms en- 
tirely or have been placed in remission by utilizing appropriate antibiotic therapy. 
I must emphasize again that these patients have been seen previously by leading 
infectious-disease and neurology experts from prestigious institutions. 

I have an elderly patient who lives in an endemic area for LD and had no expla- 
nation for the development of her inability to walk after intensive investigation by 
her medical doctors, which included a lumbar puncture, her cerebro spinal fluid re- 
vealed six bands positive for LD. Her doctors, even though she'd never received anti- 
biotic therapy, concluded that her LD was old and not active, and thus she was not 
treated. She was sent home from the hospital, and while there, fell and broke her 
hip. When she was re-emitted to the hospital she was finally treated for LD. 

There are many more patients that I could describe case studies that would as- 
tound this Committee, however I know that there are more than enough people suf- 
fering from LD here today that will describe this problem accurately. 

As a physician treating LD, I believe there are certain specific issues that this 
Committee must deal with completely and in a timely manner due to the amount 
of unnecessary suffering that is occurring in our country due to this disease. 

Diagnosis and education of physicians about LD is a tremendous issue in this 
country. At present, the diagnosis of LD must be based on the clinical interpreta- 
tions of physicians who are competent in understanding the path of physiology and 
clinical presentation of LD. By this I don't mean to State that LD should be its own 
specialty, per se, however, physicians in training need to be taught about LD by 
those physicians who are seeing the patients. I sincerely believe that the majority, 
if not all, training programs for internal medicine, family practice, and infectious 
diseases in this country are severely deficient in the skills needed for the under- 
standing and management of this disease. 

I have brought up a short case history to peek this Committee's interest in this 
problem. The greatest problem in this area is the reliance of physicians on diag- 
nostic laboratory testing for making the diagnoses, this is fraught with error in the 
diagnosis of LD due to the low sensitivity and specificity of current clinically avail- 
able tests (Lyme ELISA and Western Blot). The next issue I'd like to address which 
flows from our clinical diagnosis dilemma due to the inaccuracy of our current test- 
ing is the obvious fact that very little funding of new tests for the diagnosis of LD 
exist. Why is this the case? I believe an answer can be found in analyzing some of 
the ways funding for medical research occurs, one of the methods utilized by the 
NIH to determine the immediate need for funding research in medicine is an analy- 
sis of the Center for Disease Control's Surveillance of Disease reports. These reports 
are generated based on the incidence of disease reported to CDC. This is broken 
down by State and county. It would seem to be a very good system, and it generally 
is. With LD, however, a problem has cropped up in that the CDC has established 
extremely severe surveillance criteria which can tend to exclude the majority of pa- 
tients who absolutely have LD. This under-reporting, of course, leads to decreased 
public awareness of risk of disease and thus leads to relative complacence about im- 
mediate need for funding research. 

Last, I would like to address the issue of management of LD. Initially, as LD was 
first described, it was felt that short-term antibiotic therapv would be sufficient for 
the treatment of LD. This is not true. I have encountered patients who maintain 
positive PCR tests well after 3 months of intravenous antibiotics. Though this is an- 
ecdotal, I believe that the occurrence of this type of relative resistance to the cur- 
rently used antibiotic regiments is not uncommon. 

Dr. Allen Steer recently published an article in the Journal of the American medi- 
cal Association about the over-diagnosis of LD. I would request this Committee to 
have an independent panel of physicians and statisticians review all his conclusions 
in this retrospective study. I do believe they will find it is highly flawed and these 
inaccuracies are leading to an under-diagnosis of LD by practicing physicians who 
have read this article and not questioned it authority based on its merits rather 
than by its author. 

In addition, the various insurance companies have been using this article as a 
basis for not paying on claims for the management of LD beyond 28 days of intra- 
venous antibiotic therapy. 

In conclusion, I would hope that this committee will be able to address these is- 
sues so that the amount of suffering that LD is causing in our country can be de- 
creased and prevented. Thank you. 



14 

Statement of Jo MmcCallum, P.O. Box soee, Oakton, VA 22124 

Mrs. McCallum contracted Lyme disease while clearing brush in Minnesota in 
May 1990. She noticed that, in retrospect, she and her husband had had to remove 
several ticks from their bodies after working in the brush. Upon her return to Vir- 
ginia, she felt tired and initially thought that it was merely a bad case of jet lag. 

She subsequently developed severe fatigue, headaches, muscle aches, and 
photophobia, which are all classic symptoms of Lyme disease. Yet she was not ini- 
tially diagnosed as having Lyme. She was treated with a 10 day course of oral anti- 
biotics which did not alleviate her problems. After asking her doctor she was put 
on another 14 day course of Doxycycline. Four days after she stopped the medica- 
tion, her symptoms returned. She noted that she was exceptionally fatigued, so that 
even going to the bathroom was an arduous task. 

She was then treated with I.V. antibiotics for 16 days, followed by another relapse 
and a 28 day I.V. treatment. None of her treatments with antibiotics made her fell 
"normal," though she felt much better on the drugs than off of them. She even at- 
tempted take some medications imported illegally from Europe, which she used in 
combination with omoxycillin. She nas been off and on various medications since, 
and has currently gone 3 months with no antibiotics while feeling relatively well. 

She stressed the difficulty of living with the disease, and the need for treatment 
with antibiotics for as long as the patients needs them, rather than for set treat- 
ment period. She also noted the difficulty in getting a doctor to confirm that she 
had Lyme disease, and fears that there are many people who have the disease, yet 
live with the symptoms because their doctor tells them that they are perfectly well. 
She wants more research to be done to find a cure for the disease, and plugged Rich- 
ard Lynch from New York as a good, innovative researcher. Ms. McCallum also 
hopes that doctors will be better educated about the disease, in order to facilitate 
diagnoses. 

Statement of Pat Smith, Wall Township, NJ 

I have two daughters, Michelle and Colleen, who suffer from Lyme disease. Col- 
leen is a fifteen year old honor student who has been out of school for 3 years. She 
receives home instruction and is currently working feverishly over the summer to 
try and complete her freshman year. She has been experiencing seizure activity for 
a year and has abnormal EEG's consistent with Lyme. During the temporal lobe sei- 
zures, which can last for 2-3 days, she initially experiences speech impairment and 
a paralysis of her legs, and throughout the seizure, she is withdrawn from reality 
and experiences mental confusion, paranoia, and emotional turmoil. In addition to 
the seizures, she has had arthritic, opthalmologic, dermatologic, and other 
neurologic and musculo-skeletal symptoms of Lyme. 

Colleen has had to give up most of her childhood because of Lyme Disease. She 
was a very athletic and musical child who has had to forego all her activities and 
has experienced weight gain and dramatic changes to her fife due to Lyme. In the 
past 3 years, she has had eye problems which have not allowed her to read for any 
extended period of time without violent headaches and/or distorted vision. Through- 
out these ordeals, she has maintained a positive attitude. 

Over the past 4 years, Colleen has had approximately 5 months of IV antibiotic 
treatment with several different drugs. For the past 2 years, she has been on oral 
antibiotics. The antibiotics have helped; when she was removed from them for an 
extended time period, she relapsed. Her doctors include an internist, 
rheumatologist, opthalmologist, neurologist, MD nutritionist, and chiropractor. 

Michelle is twenty-four and has had Lyme disease since college. After oral anti- 
biotic treatment, she suffered no symptoms for almost 3 years, then relapsed. She 
is chronically tired, has headaches and recurrent eye infections. Her current treat- 
ment regimen includes oral and opthalmic antibiotics. She continues to work, since 
her symptoms are not as severe as Colleen's. 

Last year while serving on my local board of education, I prepared a preliminary 
report on how Lyme has affected nine New Jersey school districts. I presented this 
to the Centers for Disease Control and the National Institute of Health in Washing- 
ton by invitation of my Congressman. As a result of the report, CDC sent Dr. David 
Dennis to New Jersey to complete a more in-depth report on the effects of the dis- 
ease on school children. I worked with him and the New Jersey Department of 
Health to expedite the data gathering. Although I do not agree with some of the 
conclusions drawn by the CDC in its follow-up report, I believe the data collected 
speaks to the seriousness of the disease. 

There are a number of problems with the State and Federal public health re- 
sponse to Lyme that deserve Congressional scrutiny. The doctors currently 



15 

underreport the number of Lyme disease cases, primarily because the CDC defini- 
tion of the disease is an epidemiological one which has been inappropriately applied 
to diagnosis in clinical situations. Additionally, when these agencies had obtained 
useful data and case studies on Lyme, they applied the information toward focusing 
on one treatment complication of a particular antibiotic rather than focusing on the 

fllflCASfi IL8G1I 

The National Institute of Health (NIH) also possesses data, including tissue sam- 

Jiles exhibiting spirochete survival after long-term antibiotic therapy, which it has 
ailed to release to extramural researchers. 

In conclusion, I urge serious consideration be given to the testimony of physicians 
such as Dr. Burrascano who treat hundreds of chronic Lyme patients and are 
knowledgeable about the variability of symptoms and the survival of the spirochete 
even after extensive antibiotic therapy. 

Lyme has deprived children such as my daughter of their activities, friends, school 
and of their childhood; for others, it has taken their lives. You have the ability to 
stop this mmscriminate killer. Dont let our children down. Thank you. 

Statement of Carol Stolow, 43 Winton Rd., East Brunswick, NJ cssie 

A resident of East Brunswick, NJ, Carol Stolow has been directly affected by 
Lyme disease since 1990, when her three children contracted the disease. Mrs. 
Stolow knows that had she been properly educated about the cause of Lyme disease, 
her children would not have suffered the incredible pain that was caused by the bac- 
teria. As a result of her personal understanding of the trauma that debilitating dis- 
eases cause both families and individuals, Carol Stolow organized the Lyme Disease 
Network. Single handedly serving 1500 members, she has been able to organize ap- 

Sroximately 200 support groups Tor Lyme disease victims. Fortunately, as her chil- 
ren have been free of symptoms for almost 1 year now, Carol Stolow is able give 
hope to victims whose horrible experiences with Lyme disease have left them with 
none. , , . . • . , 

Mrs. Stolow's three children have Lyme cases that are presently m remission, but 
she and her family suffered for 2 years while her daughter, Kimberly, battled Lyme 
disease at home. Her contact with thousands of Lyme victims has made her acutely 
aware that in most instances the bacteria is not easily diagnosed. In fact, most doc- 
tors are unfamiliar with the disease and it is commonly misdiagnosed. Like many 
other Lyme disease victims, Mrs. Stolow's children were not diagnosed immediately. 
She was accused of having marital problems that caused her children to act abnor- 
mally, and her daughter was accused of imagining her symptoms and "faking it" 
with her best friend, who also contracted the disease. Carol Stolow described an en- 
counter with her fourth doctor who said, "I would be more likely to believe that 50 
people standing at a bus stop could have the same psychosomatic disorder than I 
could believe that these two girls have Lyme disease." Fortunately, the fifth doctor 
accurately diagnosed her children with Lyme disease. 

Carol Stolow administered three intravenous treatments to her daughter over the 
course of a year. In the months following, Kimberly received antibiotics and her con- 
dition seemed to improve. However, once she was taken off of the medication, the 
symptoms returned with a vengeance, and eleven year-old Kimberly suffered sei- 
zures, loss of vision, loss of appetite, rapid heart beat, loss of concentration and pain 
that was so unbearable she awoke screaming. After 9 months of aggressive therapy, 
all three children remained symptom free. Yet, Carol Stolow would be in constant 
fear of her children suffering relapses if she allowed the disease to control her. 
While forming the Lyme Disease Network has given her the opportunity to help oth- 
ers find proper health care, it has also given her the strength to regain control of 
her life. 

Recently, Carol Stolow has received an increasing number of calls that she feels 
unqualified to handle due the severity of the callers' problems. She has discovered 
that on the average, a Lyme disease victim sees nine doctors before they are prop- 
erly diagnosed. By the time they come into contact with the Lyme Disease Network, 
they are often out of work, out of money and are receiving no moral support. This 
is often a result of insurance agencies throughout the country that are finding loop 
holes in their policies which leave patients without coverage. Mrs. Stolow has found 
that while insurance agencies refuse their patients coverage because of "above rea- 
sonable and customary prices", these patients are in many cases receiving the most 
inexpensive care available. Their misdiagnosed, undiagnosed and unaddressed Lyme 

disease has left many victims without hope and Mrs. Stolow is, "not trained for sui- 
cide prevention." 
Entire families are often infected with Lyme disease. One family that Mrs. Stolow 

works with has been fighting the disease for several years. A mother of three, 



16 

Donna has been working twelve hour shifts at a hospital where she is a Registered 
Nurse, in order to receive medicine for herself, her husband and her three children 
who have Lyme disease. She is able to purchase medical supplies at reduced rates, 
and is qualified to administer her family treatment. However, her insurance policy 
recently revoked her coverage because the insurance company did not feel that the 
treatments were medically necessary. Donna is ill herself, but nonetheless, she must 
work long shifts to pay for the medication. This is just one example of a family that 
faces financial destruction because of Lyme disease. 

Carol Stolow believes that it is essential for the ignorance surrounding Lyme dis- 
ease to end. Because Lyme disease manifests itseff in many ways, the Center for 
Disease Control's criteria is completely inadequate. For this reason, hundreds of 
thousands of Lyme disease victims go unreported. Also, the media fails to accurately 
report the deaths of Lyme disease victims, and as a result, the American public is 
unaware of its devastating results. Through The Lyme Disease Network, Carol 
Stolow organizes lectures, provides a phone service, and writes a newsletter. She 
tells her callers of her own success with the disease, but Carol Stolow feels that 
until the serious issue of Lyme disease, second only to AIDS in its number of infec- 
tions, is addressed people will continue to suffer. 

Carol is testifying about Lyme disease as a victim of Lyme disease and as mother 
of a family afflicted with the disease, not as the director of the Lyme Disease Net- 
work. 

Statement of Richard and Carole Tegnander, 59 Sobro Avenue 

Valley Stream, NY iimo, Phone and Fax: (5i6) 286-7075 

Richard and Carole Tegnander have had their normal, average American lives 
disrupted and nearly destroyed by Lyme disease; a ravishing disease that has irrev- 
ocably altered the normal lives of thousands of Americans like the Tegnanders. The 
attached letter chronicles the Tegnanders travails with doctors and misdiagnoses to 
a final realization and acceptance that they both suffer from Lyme disease. Hope- 
fully, the letter also captures the desperation of the Tegnanders and the extreme 
weariness they feel from years of combating inertia and ignorance. 

Carole Tegnander was subjected to a slew of false diagnoses by doctors ignorant 
of Lyme disease. She and her husband were subjected to an emotional rollercoaster 
with each misdiagnosis. The diseases Carole was told she had were serious and in 
many cases deadly. When Carole was diagnosed with M.S., Richard was devastated 
to learn that this disease would eventually kill his wife. With the realization that 
this was a misdiagnosis, Richard and Carole were mildly relieved but also daunted 
by the prospect of some other unknown disease that might be attacking Carole. 

The degree of incompetence about Lyme disease that the Tegnanders faced is best 
illustrated by the story of Carole's misdiagnoses. When she was diagnosed with 
Lupus, she and her husband joined a Lupus support group only to be told by sup- 
port group members that Carole didn't have the symptoms of Lupus. After being di- 
agnosed with epilepsy, Carole's doctor prescribed a common epilepsy drug which 
caused her to lose consciousness repeatedly. After being diagnosed with severe ar- 
thritis, Richard and Carole joined an arthritis support group. In this group, they 
found others who had experiences similar to their own. This group began to meet 
separately from the arthritis group and eventually grew into the Long Island Lyme 
Association (LILA), the first support group for Lyme patients on Long Island. 

Richard is co-founder and vice-president of LILA. He is also an administrator with 
the Nassau County Parole Commission. In addition, he works as a part-time night 
teacher, teaching English and history to foreigners. Carole works in a nursing home. 
They have kept their jobs and continue to lead productive lives. However, Lyme dis- 
ease is a continual drain on their energy and financial resources. In addition to the 
painful fatigue that the disease brings, Lyme not only drains the Tegnanders phys- 
ically, but their financial resources are also strenuously taxed by their medical cost. 
Their financial plight was exacerbated when, during the very early stages of their 
respective treatments, the Tegnanders insurance company stopped covering the cost 
of their Lyme treatments. 

According to the Tegnanders, they are not the only Lyme patients to be aban- 
doned by their insurance companies. The Tegnanders stated that the CDC has es- 
tablished narrow criteria for reporting Lyme cases. These criteria require an indi- 
vidual to have an "^M." rash (bullseye rash) or a positive blood test in addition 
to multiple physical symptoms to be considered a "reportable" case. Unfortunately, 
insurance companies often rely on these criteria for the basis of their coverage. If 
a case does not meet the criteria, the company may deny insurance reimbursement. 



17 

The Tegnanders feel that this is not fair, and it is not what the CDC intended when 
they established the criteria. 

Beyond financial concerns, a larger specter looms on the horizon for the 
Tegnanders. There is a constant fear that the disease will suddenly take Carole or 
Richard without warning. This thing is killing us," Richard states simply. "One day 
we will die from this." 

The Tegnanders are not only concerned with themselves. They are troubled that 
people know so little about this disease, the second fastest spreading disease in the 
country. They are concerned that the common hiding place for the tick that spreads 
this disease is grassy wooded areas. "Places where children play," Richard says. 

European doctors are much more informed and knowledgeable about Lyme dis- 
ease than their American counterparts, according to the Tegnanders. Europeans are 
actively engaged in research and public awareness campaigns against the disease. 

The Tegnanders' primary concerns about the disease are as follows: 

there is no test tor Lyme; there is little research being conducted; the rash that 
indicates a Lyme infection occurs in only 40% of those infected and typically occurs 
in places where it may go unnoticed; there is a lack of education about the disease; 
ana doctors are afraid to diagnose Lyme patients due to fears about malpractice as 
well as the absence of an FDA approved drug for treatment and of a approved meth- 
od of treatment. 

Letter From Richard and Carole Tegnander 

My name is Richard Tegnander. I reside in New York, and I am a "victim'* of 
Lyme "misdiagnosis." 

In the early 1980's I was living the American dream. I owned my own home. I 
had a beautiful wife, a handsome son, a good job, but most of all, I had my health. 
Then in 1985, my dream became a nightmare. 

It began so subtly that I did not see it at first. It began with my coming home 
from work and finding my wife lying on our sofa, crying uncontrollably. I imme- 
diately thought of all possible tragedies. How ironic that it should turn out to be 
worse than I could have imagined. My wife, Carole had been working as a secretary 
at a local high school. She related to me that of late she had been coming home 
so exhausted that she hurt all over. She spoke of vague aches and pains. A stiff 
neck, a ringing in her ear, a sore throat, headaches, blurry vision, spots before her 
eyes, dizziness, loss of memory, slurred speech, loss of sensation on the side of her 
face. She began to experience knee swelling and pain. She suffered from lower back 
pain. She experienced "heart flutters," difficulty sleeping, uncontrollable muscie 
twitches. 

It was at this point, early in 1986 that our odyssey of visiting doctors began. 
There were dentists, oral surgeons, allergists, neurologists, orthopedists, cardiolo- 
gists, endocrinologists, chiropractors, internists, rheumatologists, and more. Each 
specialist" had his or her own ideas as to what was causing the problems. Each 
had their own battery of tests. Each had their own diagnosis. 

My wife had Lupus, M.S., epilepsy, Sjogrens Syndrome, TMJ, rheumatoid arthri- 
tis, allergies, was suffering from some form of psychological disorder, stress, PMS, 
to name t>ut a few. It was not until a Rheumatologist, upon reexamining her, de- 
cided to test for Lyme disease. Two tests later, he said she did in fact have Lyme 
disease. He treated her initially with oral antibiotics. She felt better, and he said 
she was cured. 

During the 5 years it took for my wife to be diagnosed, I'd followed her from doc- 
tor to doctor, test to test. I was experiencing fatigue, heart "flutters" and occasional 
headache and dizziness. Our family doctor said it was stress from my wife's condi- 
tion. At my wife's urging I agreed to be tested for Lyme. Sure enough my tests came 
back positive, also. Like my wife, oral antibiotics did not work, and I too underwent 
I.V. treatment. Like my wife, I felt better also. A few weeks passed, and my wife 
began to experience a recurrence of her symptoms. The doctor who had treated her 
refused to put her back on antibiotics. You see 3 weeks of antibiotics was all that 
was called for Lyme disease. 

The search tor answers continued. Again, doctors tested and doctors prescribed, 
but my wife and later myself did not get better. You see, I too relapsed. It just took 
& little longer. 

Finally, we came upon a doctor who gathered together all our records, all our 
tests, did his own testing and determined that there was still active Lyme infection. 
He treated us with various antibiotics, and in time, we responded favorably. I have 
been in remission for the past year. My wife, unfortunately, continues to be treated 
with antibiotics. 



18 

As I stated in the beginning, ours is a story of the American dream becoming the 
American nightmare. We have suffered physically, emotionally, and financially. Our 
health had deteriorated, our friends, family, even cc-workers shun us. They do not 
understand what the hell we are going through. But you look great," they say. Little 
do they realize the struggle it has been to continue working, trying to keep up some 
semblance of normality. 

Doctors who have not been blessed with infallibility, try to justify their own short- 
comings by stating that they don't understand. We, after all, are not doctore and 
should not presume to be doctors. Nothing could be further form the truth. The 
truth is that we trusted our doctors. We listened to their every work. We believed 
they knew what they were doing. But time and time again, these doctors did not 
diagnose us; they misdiagnosed us. These doctors did not treat us; they mistreated 
us. 

To say Lyme disease is over-diagnosed is to say that Lupus, M.S , epilepsy, and 
arthritis are over-diagnosed; for these were all attributed to my wife and later to 
myself. A day does not go by that I do not heat of another unfortunate individual 
who has had to run the gauntlet of doctors and diseases before being diagnosed with 
Lyme. These people did not go out and seek Lyme disease. Lyme disease found 
them. 

Much of the rationale for saying Lyme is over-diagnosed is based upon negative 
blood tests. Are we to believe that only Dr. Steere's Blood tests are valid, while all 
others are either "false-positive" or "false-negative." Its the test, stupid! These is no 
valid test. 

Until a reliable test is developed how can any one say when Lyme disease begins 
and when Lyme disease ends? If someone tests positive and has symptoms but nas 
already received the prescribed 3 weeks of treatment, then it must be a false-posi- 
tive test. Why couldn't it also be chronic, persistent infection? 

How can anyone be so positive about a disease that was unknown until approxi- 
mately twenty years ago? It's interesting to note that Dr. Steere didn't get up one 
morning and say, "I think HI drive down to Lyme, Connecticut and discover a new 
disease. It was a group of mothers who would not dismiss their children's problems 
as just arthritis. They demanded more from our medical profession. Further, Dr. 
Steere might have put together the evidence and found a new disease that was 
transmitted by a tick, but he did not know it was a spirochetal bacterium that 
caused the symptoms. That took another 10 years. 

We are not asking for miracles, although we might silently pray for one each 
night. What we do want is honesty, open discussions, exchanges of information. Is 
that too much to ask? Polarization of views must stop. People are suffering. People 
are dying. We are sick and tired of being sick and tired. The time for posturing must 
end. 

Won't help us wipe out Lyme in our lifetime? Thank You. 

Statement op Sallie Florence Timpone 

My name is Sallie Florence Timpone. I reside at One Austin Place, Hasbrouck 
Heights, NJ. I am married and mother of three children ages eleven, seven and five. 

I nave been suffering with Lyme Disease for twelve years. When infected in 1981, 
I had all of the classic symptoms. My torso was covered with a very large, expand- 
ing bull's eye rash. I had Acrodermatitis Chronica Atrophicans (ACA) on both legs. 
This is a classic sign of a spirochetal infection. My legs, from my knees to my an- 
kles, tripled in size, became very black and blue and were covered with large hard 
lumps. Three dermatologists and my trio of doctors were mystified. All they could 
do was prescribe cortisone cream. My symptoms for the next 7 years varied greatly. 
They included (but were not limited to) severe headaches, disorientation, blackouts, 
snooting pains down arms and legs, eight "kidney stones" (diagnosed but never 
found), light sensitivity, and PAINT .. migrating pain, stabbing pain, muscle pain, 
neck pain, you name it— it hurt! 

I visited no less than sixteen different doctors. I was told I could have everything 
from multiple sclerosis to Bored Housewife Syndrome. I was asked questions like, 
"How is your sex life?, Do you love your kids?^. I was sent to a psychiatrist. I was 
given every test known to man (CAT Scan, MRI, etc.) and was told there was noth- 
ing wrong with me. I begged doctors to explain my pain. They all wrote me off as 
"nuts". In 1988 I watched a television show about Lyme. It showed the rash and 
explained the symptoms. I talked it over with my husband and other family mem- 
bers that remembered the rash. We all agreed it was too much of a coincidence. I 
went for a test. My first test was "equivocal" so I was sent to an infectious disease 
doctor. This guy was actually excited about my history. He said I was a classic case. 
My Lyme tests showed up positive — both blood and spinal fluid. I was told by new 



19 

ID doctor, "If you have to have an infectious disease — Lyme is the one to have. 111 
have you cured in 2 weeks!". Needless to say I was overjoyed. After 7 years of 
searching for something — anything — I had found the answer. I wasn't crazy after 
all. 

It has been 6 years since I got that initial promise of a cure. Not much has 
changed — except that Fm a little poorer, a little sicker and very, very frustrated. 1 
have tried just about everything I could possibly try to get myself better. I've found 
that three to 6 months on strong IV antibiotics seem to help keep me on my feet. 
I am not wealthy — I have already lost my insurance once. I may lose it again. Lyme 
Disease has made my life very difficult. The medical and insurance industries and 
the State and Federal governments have made it almost impossible! I am forced to 
fight every day for my nghts as a patient. 

I don't think Lyme patients are asking too much. We simply want to be believed, 
we want to be treated with respect. We want our government (state and federal) 
to fund research for a CURE for CHRONIC Lyme Disease. We want someone to put 
the insurance companies in their places and insist they stop practicing medicine and 
simply pay for it like their contracts promise! 

Thank you for the opportunity to share my thoughts with you. I sincerely hope 
you can make a difference. 

As a matter of record: I sit on the New Jersey Governor's Lyme Disease Advisory 
Council, I am Vice President of the Lyme Disease Association of New Jersey and 
am a founding member and past president of the Lyme Disease Coalition of New 
Jersey. 

Contact number (201)288-3463. 

Statement of Eileen Wade, 474 Pemburn Dr. 

Fairfield, CT 08430, Phone Number: (203)336-42*) 

Eileen Wade of Fairfield, Connecticut contracted Lyme Disease when she was a 
teenager, but went undiagnosed for years. During her illness, Eileen has visited 
thirty physicians in search of diagnosis and treatment. Wade has been hospitalized 
at various times during her illness, and she adds, "the past 10 years have been dev- 
astating." 

Ms. Wade suffers from a number of medical problems due to Lyme Disease. Wade 
has been left sterile. Wade has also had many neurological problems and seizures 
during the past 10 years. She has experienced temporary blindness, and at other 
times nas been totally unable to walk. 

Ms. Wade, who is a single parent of a daughter with no child support, has been 
unable to work for 4 years. Before the disease left her unable to work, Wade was 
a regional manager for a large corporation with, in her words, "a good salary and 
a company car." Now she and her daughter have moved back in with her parents 
to try save money because the costs of treating Wade and her daughter Heather 
total close to $ 1 million. 

Heather Wade was also diagnosed with Lyme Disease 4 years ago and she is se- 
verely ill today. Heather has not attended school in 3 years and has been hospital- 
ized often in that span. Wade said, "Heather is bed-bound today and in the care 
of her grandparents, which is why she is not here today. She wrote a report about 
Lyme Disease that I would like included if I may." 

Wade also said, "We will reach the lifetime maximum on our health insurance 
soon. Because of Lyme Disease, I am uninsurable. I don't know what well do." 

Ms. Wade added, "We desperately need help. We have to leave our State to be 
treated." In fact, Ms. Wade travels three hours to a hospital on Long Island for 
treatment, while her daughter Heather goes to a hospital in New Jersey for treat- 
ment. Heather has undergone 6 weeks 01 treatment since January, and Eileen has 
to relocate to New Jersey each time to care for her. 

Ms. Wade stated, There is no question that Lyme Disease is a chronic persistent 
infection. Long-term antibiotics are required. New antibiotics must be developed for 
those of us who are treatment failures. The disease has devastated our lives. I have 
had to move back in with my parents in an attempt to save money." 

Ms. Wade said, "My daughter was a dancer before Lyme Disease struck. She used 
to be a gymnast and a cheerleader — now she can't do anything at all. Her memory 
loss is so severe that she can't tell the difference between a nickel, a dime and a 
quarter." 

Ms. Wade concluded. The diagnosis took so long, that I took for granted the fact 
that I was going to die. When I did not know what I was afflicted with, I tried to 
separate myself from my daughter as much as possible to protect her. Finally, even 
though we have problems, I wish that you could see the other Lyme Disease pa- 



20 

tiers ts in the Jersey Shore Hospitals who are worse off than us and see their suffer- 
ing." 

Wrhtek Report Submitted as Testimony by Eileen Wade on behalf of 

her daughter, heather wade 

474 Pemburn Drive, Fairfield, CT O64so 

Phone #: <203> 336-4280 

being alone by heather wade 

When I was bora they gave me my last rites and told my mother there was a 
good chance that I could die. With that, I was kept in the hospital, on and off, 
throughout the first 2 years of my life. I was very sick, and I stopped breathing at 
my house twice. Then I was admitted into Yale/New Haven Hospital, where I was 
diagnosed as having pneumonia and another rare disease. After the first couple of 
years being ill, the medicine seemed to have taken effect and everything was going 
alright. I was alive, kicking, and healthy or, at least, that's what the doctors 
thought. 

Then, about 4 years later, when I was around six, I started feeling sick again, 
but they never related it to my illness as an infant. I was told I had pneumonia 
several times, that I had strep throat, bronchitis and scarlet fever. Yet, still there 
was something wrong and I just wasnt [sic] feeling right. This lasted about 2 
months and then all the sickness disappeared. 

Again, when I was ten I went away to camp for about 3 weeks. During the entire 
time that I was at camp I had a terrible rash that developed in the first couple of 
days. It spread across my whole hip, but I didn't mention it to any of the counselors. 
When I got home from camp, I showed my mother this awful breakout. She brought 
me to the doctor and he said I had impetigo. 

After this experience I became very sick with severe migraine headaches, Joint 
pain and arthritis so badly that they had to put my leg in a brace. I also suffered 
with dizziness, heart palpitations, tiredness, and inability to sleep. 

We never thought that all of these things were related to each other and life a 
went on. Even though about 50 percent of the time I was sick, I still led a normal 
life by taking dancing, which I had been taking since I was three, and by taking 
gymnastics and violin lessons. One night after a violin concert, when I was about 
twelve, I was changing into my pajamas and I noticed something on my neck. I 
called my mother to my room ana she said it was a tick. She was a wreck, so she 
asked my grandparents to take me to the hospital. She, at that time, was too sick 
to take me to the hospital, because she was suffering from an illness, but no one 
knew why she was so sick. 

Anyway, when I went to the hospital my mom gave strict instructions to my 
grandparents to ask about Lyme Disease, a new disease she had been reading 
about. At the time she was reading about many diseases, because she was so sick. 

When my grandparents and I arrived at the hospital, the doctors removed my 
tick. Aa my grandparents were told, they asked the doctor if it could be a Lyme tick 
land he said, "Oh, no, there are no ticks like that around here." 

So we went home and didn't think about it again. I was often sick through sixth 
and seventh grades. I was hardly ever in school and my grades were increasingly 
dropping. Finally, when I reached the eighth grade, I was out of school more than 
I was in school. I knew something was wrong with me. I couldn't sleep for days; 
then when I did sleep, it would be for at least eighteen hours a day. I had such 
awful headaches that I would end up throwing up everywhere. Sometimes I would 
wake up in the morning unable to move for hours, either because there was excruci- 
ating pain, or my joints would lock up. Sometimes I just couldn't [sic] move at all 
and would literally become paralyzed. I was dizzy and blacking out, which would 
sometimes make me fall or faint. I had heart palpitations, which meant my heart 
would beat erratically. For example, 1 minute my heart would pump out of the blue 
as if it just jogged a mile, then a while later, it would barely be circulating. 

I often lost feeling in certain parts of my body, and there were times that with 
my 20/20 vision I couldn't see anything. I often got sick to my stomach and had 
awful cramps. I developed back and neck problems that landed me in physical ther- 
apy. Sometimes Fd [sic] get ringing in my ears so loud that I couldnt [sic] hear a 
thing. 

By the time all this happened I was convinced that I was chronically ill. I told 
my mother and she also knew something was wrong with me. I was at the doctor's 



21 

office about three times a week and the doctor kept saying that I had ear infections, 
mono, and every other virus. But, I knew it was more than that. 

My mother had just undergone major surgery and had been very sick. Alter see- 
ing many doctors in many states, she was diagnosed as having Lyme Disease. She 
insisted that I be tested for it also, but my doctors kept telling her that she just 
had a phobia about it because she had the disease. They told her that she was para- 
noid and that I had nothing serious. 

Months went by where 80 percent of the time I was unexplainably ill. To everyone 
it was a mystery because 1 day I could be completely healthy and the next day I 
would be incapable of moving my own body. 

Incidentally, at this point in time, which was the eighth grade, my mother was 
rushed to the hospital. She was extremely sick and the doctors told my grand- 
parents that there was no way my Mom could make it through the night and that 
she didn't have much longer to live. But, somehow, my mother pulled through and 
she had to seek othernelp. She came across a doctor in Long Island, Dr. 
Burroscano, whose son also had Lyme Disease and who, at the time, was one of the 
only doctors who was aware of the effects of Lyme Disease, which was probably due 
to his contact with it. 

My mother was put on I.V. antibiotics and after a few months came home where 
she had a nurse taking care of her and remained on I.V. She kept in touch with 
Dr. Burroscano and continued to have regular visits to his office. 

She was doing a little better, but I on the other hand, was not. She knew some- 
thing had to be done, so she mentioned it to Dr. Burroscano. He had me go in for 
testing. This was at the beginning of my freshman year in high school. By December 
of the ninth grade they had discovered that I also had Lyme Disease which I must 
have contracted during birth. This explained why I was so sick when I was a baby, 
but I still didn't understand why it didn't show up again until years later. I was 
told that the disease can remain dormant for years. I also got bitten by ticks on 
several occasions which may have made things worse, and the rash when I was 
younger, which had been described as impetigo, was a tick rash, which meant that 
I had also caught Lyme Disease then. Finally, everything was fitting together. 

As a result of my getting sicker and sicker, I was taken out of school by the begin- 
ning of January in my ninth grade year. The doctor immediately put me on I.V. 
antibiotics (Roseprin), and several oral medications. Yet, I remained sick, and noth- 
ing was helping. I had fevers almost every day, and on the days that I didn't, my 
temperature was too low. I almost completely stopped breathing on three occasions 
before passing out. I developed seizures, arthritis, hypoglycemia, thyroid, and res- 
piratory problems among medical problems. As a result of my heart problems, they 
had to put me on a heart monitor. 

One day I awoke and found that I was swollen. Each part of my body was at least 
twice its size. My knees were so swollen that I could barely bend them, let alone 
walk. My feet were so swollen that slippers wouldn't fit on them. The head-to-toe 
hives were unbearable; they were itchy, Durned and they stung. I had to go to the 
hospital in New York because my doctor practiced there. He also recommended a 
neurologist, Dr. Petruica, to see me because of all my neurological problems. She 
also specializes in Lyme Disease. Both of these doctors are top doctors in this coun- 
try for this. They are both also on the Medical Advisory Committee on the Lyme 
Bosrreliosis Foundation, which consists of sixteen world-wide doctors. In each of the 
doctor's offices I have met people from Canada, California, Michigan, etc. 

Anyway, while I was in the hospital they were afraid that because of all the swell- 
ing that my throat would close. During my stay at the hospital I also lost the ability 
to see. Because of all the seizures I was having, the swelling in my brain (encepha- 
litis) put so much pressure on my eyes that it blinded me. I fainted once and had 
continual problems moving. But, worst of all were the headaches; they are always 
the worst. The encephalitis makes my brain too swollen for my skull. The pain in 
my head actually makes me vomit and cry. I can't describe such pain. I could no 
longer urinate because my brain could not send the message which is necessary. 

Thinking is an every day problem for me. That is why my grades and intellectual 
status dropped so quickly. I have lots of neurological problems that make it impos- 
sible to think straight. Even left from right becomes confusing for me. Also, on many 
occasions I'd go for a walk down the street and wouldn't be able to find my way 
home. As a result of the confusion this disease causes, I cannot attend school. 

While at the hospital I get inflammation of the ribs and I also become paralyzed 
from my left shoulder all the way down to my hand. I've had several stays at the 
hospital. My last one was November/December of tenth grade. The last time I was 
there they feared that I could actually have a stroke. 

I've been doing much better since the last time I was at the hospital, but I am 
still very ill, although I dont act it. My main problem is getting my thoughts 



22 

straight from the confusion this sickness causes. My mother is also very sick at the 
moment. The saddest part of all this is the fact that both my mother and I almost 
died because of a bug about the size of a freckle. 

But there is a bright side to all of this, and that is the fact that I am back in 
school and I've met many nice people through support groups and trips to the doc- 
tor. Because this disease has had such a permanent effect on my life, like the fact 
that I may never be able to have children, I decided to write about it and try to 
make people more aware. 

Ms. Wade adds, "My daughter wrote this one and a half years ago. She was only 
able to attend school part time for 2 months in the past 3 years. Heather is still 
very ill. She will gladly speak to anyone who would like to know about Lyme Dis- 
ease." 

Statement From Evan White and his mother Ruchana 

so Tranquility Road, Suffern, NY 10901 

"Everybody helps when everybody knows everybody can get together and help. I 
want help now." Evan White— July 30, 1993 

Until September 1990, Evan was the most popular boy in his class, an outstand- 
ing athlete, and an excellent student. 

All of this changed, however, when Evan came down with flu-like symptoms. Be- 
cause his area is endemic to Lyme disease, his doctor ordered that he be tested; the 
results came back positive. He was then referred to a pediatrician who specialized 
in infectious diseases and was started on a treatment of oral antibiotics. 

Evan did not respond well to the medication. He had severe headaches and was 
unable to raise his head off the pillow. He was given the drug rosephin intra- 
venously and as a result developed gallbladder sludge. During this period, Evan 
never had a blood test, nor did he receive treatment for the side effects he was suf- 
fering. 

Evan was referred to a pediatric neurologist who said that he was not medically 
ill. The pediatrician declared Evan's sickness psychological, despite the fact that the 
original blood tests snowed that he did, indeed, have antibodies to Lyme disease. 
His parents, obviously, were confused: "You don't want to be sick when you're elev- 
en, on the travelling soccer team, an excellent lacrosse player, and have many girl 
friends." However, they had placed their faith in the doctors and found it difficult 
to question their prognosis. As a result, medication was stopped, and Evan began 
seeing a psychologist. 

During the third month of psychological treatment, Evan's parents finally con- 
vinced the doctors that his illness was not "psychological": his head would fall to 
his shoulder, he was beginning to atrophy from head to toe, and his hearing had 
becoming so sensitive that the slightest noise was deafening. 

The Whites went back to their original pediatrician who ran a complete battery 
of tests. It was then that they discovered that Evan's Lyme disease had "sky- 
rocketed . Because there had been no treatment during the crucial part of his illness 
the disease had ravaged his body. The doctors were forced to admit that they did 
not know what to do. 

In April 1991, the doctors placed Evan in a hospital and prescribed the drug 
Clafrin intravenously. He could not walk, would scream due to the severe pain of 
his headaches, and his speech was beginning to become unclear. Evan spent 2 
weeks in intensive care during his two-month stay in the hospital. During this time, 
he also became desensitized to the Clafrin. 

That summer, Evan made many trips to the hospital. He was dehydrated and had 
to receive naso-gastric feedings. He was then sent to a children's specialist hospital 
in New Jersey. His great pain caused him to scream day and night. At this point, 
his parents described him as being "completely gone in body and mind"; he could 
only recognize his mother and father — sometimes. 

Evan has begun the slow road to recovery. He has attended the Helen Hayes Day 
Hospital for the past year and a half where he receives intensive rehabilitation 5 
days a week. He has received multiple types of therapy: occupational, physical, 
speech, and acupuncture. The results of these painful treatments were evident by 
February 1992: he had strength in his hands. 

His progress has been very slow but steady. His legs, arms, and head are much 
stronger now. He is able to get around with the use a walker. Although he can only 
speak a few words, his vocal chords have not been damaged, nor has any other part 
of his body. He is much more aware of his surroundings. He has feelings ana de- 
sires, and he wants very much to let the government know how catastrophic this 



23 

disease has been to his life. He feels that there is a way out of everything and that 
there must be a way out of this as well. 

Obviously, Lyme disease has had a devastating impact on Evan's life. Although 
he was one of the most popular boys in his class, he no longer has any friends. 
Classmates continue to call and to send post cards, but Evan refuses to see them 
until he is well. The trauma of watching Evan suffer has taken a toll on his older 
brother, who is in college, and his sister, who is currently applying to medical school 
as well as researching Lyme Disease. Fortunately, Evan's family has health insur- 
ance — his illness has cost over $2 million so far. 

He has lost his education. He can no longer read or write and has not attended 
school in over 2 years. School is difficult; he cannot identify words but sometimes 
something in a newspaper will jump out at him. He knows everything is locked 
away in the back of his head, but he is unable to find a way of accessing his knowl- 
edge: "Sometimes I feel like I am in a bubble, but just can't get out." 

Evan communicates through hand gestures. Frustrated with his situation, he is 
often angry and irritable. He has no appetite; although he is five foot four inches, 
he weighs only eighty pounds. He suffers from insomnia. He enjoys watching tele- 
vision, but without any sound — any noise is deafening, even though he wears 
earplugs and headphones. His voice has changed and matured. "Help is the word 
that he repeats most often. 

Evan has many questions: "Why me? Why did this happen to me to make me so 
sick? Why is no one helping me? He is aware that he is losing his childhood. He 
is now fourteen and wants to be a teenager and to play lacrosse and soccer and to 
have friends and to socialize. One day he would like to be a psychiatrist and a 
stand-up comic — he feels that he has plenty of experiences upon which to draw. He 
wonders how this is possible when he is chronically ill. He desperately wants others 
to hear his story so that no more time will be wasted and that a cure will be discov- 
ered. 



24 



FAXES AND LETTERS 



July is, 199) 

HMt.h A. Da»a 
3 Hohlng'ron Court 
Holei'1, » J 077)1 
lioai lti-ttit 
tint) 949-S911 



To whoa It amy concernl 




ctlerrpta" to tetnirate tltl* tre'taent li"«u] tlrrf, but ea^n 1 1 ra h«* hea 
knlere-ed, rfl entltlotlce tela tried to ruler* lie health but th-y were not 
eurtlclently effective and Inttavenoua antltlotlc treatment had to i« r-etatte 
to attest potentially 1 ! 1 e- t''t r«t cnlug d-cllnea In hla neurological and catdla 
ayste**.. In every cbi«, the Intravenous treatment was effective In gradually 
relieving hla ayeptone and rnatorlng hla haalth. 

Hy aon'a fllnees hea teen ohtonlc lacuna ha we hoi dlaanoned c-n a ilraly 
boils In 1991. In tha fall or 1991 h- euffered with ihnltlant pain and 
ne"rol'-glcal conrl 'cnt lent for three "on'bi, Including Lyra Menln-rltle, before 
ho va-* dlaqno-erf. Curing thla pail n d n f hi* illncai, ha revalnad ptone Cor 
wenke becnuse the ptcasute and pain In hla head and neck vara ao aavara ha 
could not ralaa hla head. 

Jho rallura to dlegnoee ay aon'a llln^aa In )Q9l o-cut'ed ivin though Me eyap- 
Icaia v-tt" catenae and m-< rU'li with lyn Dlaenee and even though ny {."ally 
llvee In Honnouih county, (lev .leteey wh-te doar tick*' at" prevalent and Lyae 
rola*eee ha* ona of tha Mghovt rataa of Incidence In ti<a |i«tt of Haw jara*-y 
and In tha country. "n« '-ould rraaonably ballava that the p"bll--lty about lyaa 
Clitut In II- » Jarary »n eufMcl'nt to «Inl "11 d- ctota to tha ayaptoaa of 

thla HI but Hint 1" n t the ca-t. There la a health problee occutrlna 

•crail ot rountry which la atrlklng Innocent ehlldran and adulta. Action la 
required to ri'ltm thla altuatlon. 




I hope tiiat letter* auch ea rln- will heir you "nriarat-tnd tha trua natura and 
ne-jatlve lr«rart of Lyre Dleee*e on tha children and adulte of our nation. Lyaa 

Hall thet'a ay aon'a Ufa for tha leat Ji von tha. And that'a tha eeae atory you 
you will hear frca hundrede of othare. If you get Int" the real world In tha 
hsr-pltal wet'ia and doctnr'a oftl-es where the vlcttas of chronic lyaa Dle<-aee 
• cck eedlcal treatacnt. lhlt la not tha atory you will hear froti tha CDC or 
fro» certain "*"at»Tn f.atnbl lnh-.ent* »edlcal reaenrchera. 

Thla •loenn't quite <- |nclde vlth tha -.antra th-t Lye Dlteaee only re-jultee tour 
wcrke or entlMotle tiea'eent. It la tru» tliat "-any vlctlaa of Lyae Dl-eate do 
recover nft-r ehott-teta antlblotlca and other- never devlop "vartooa at all. 
But If Lvre Dleenae were really thet altple to cure, then what la happening? 
In thete eo»- other e>e'erlo'ie. "nldent I f I'd llln-je In the ether caualng 
chllJr-n a"d adulti all ov-t the nation to auftcr froa the u-i nyaptoae ■ Mot 
rrnpla who dr. el r 'htonlc en 1 aa eta tyro nlaeea- usually do ao b-cauaa their 
rhyolclan falle-1 to teccjnlta and tteat tha a-^rly ayartcaa of Lyno Olaeaaa. 
lyne rl-ea-o la a cc-p! Icat»d. nul t 1 -ayn te-l c dlaen-a with highly verl«bla 
lr»p->cta on dlffarrnt recple. only further teae'arch and knowledge will unfold 
tha «nyeterlr»e of Lyme hla»»aan. 

Miyalcl/ini do n-t properly dlagooa- lye- Clacaa- for aany irinom. flrit, they 
retely co"eld-r »h» ponalbllliy or lyae Dla-eae, and whan Ihey do, a-nY doctora 
dlatei.nd tha well docurenfd fict th"t all generally available lyae Oleease 
tnte yield falsa negstlvee and fnlna roeltlvea. t»ioy coapletaly l-rnore the 
ey»pior.atoiogy of th-lr p->tlen«e, a"d th-y fell to deliver aedlral ttnUcni, 
evno when contronted with a pella-t with a clunler of ayarloaa. uneaplalned by 
any ctl.rr d-tecteble lllneaa, Bn1 cla-rly u-ocln'lf with Lyae Olneeaa. Jn 199J 
rrorle hove pres-nted theaerlva to • d-ctor with erytiira -Hr»»i rnah with the 
lnfTin-tlon U.at >h-y oiea.ved the tick hlte, and that tha tick waa t-atad at a 
nral'h center end r-und to he a poeltlve cerrler of the i.nc'erla that canaea 
tyaa Dlarase. They were d'Tit awny with no rlln-inoala and no pravcntatlva traat- 
ai»nt. That'a outrageoue. Iiaaglna how you would faal If thla happened to you. 



25 

Imagine It you also suffered from Lyme Meningitis or seizures like sobs Lyme 
Disease victims, end your doctor say* "you ere Just crer.y" or "stop faklri 
those behaviours or I will request a psychiatric exaa." Imagine es you lie In 
In e doctor's office with severe, headaches, neuralgia, tachycardia, shooting 
pains In muscles and Joints, and other symptoms end your doctor proclaims you 
are not sick because all tenta are negative. Imagine your doctor won't prescribe 
■edlcal service because of intimidation from other physicians or government 
agencies. All of this and more Is happening all over our nation, now In 1993, 
even though we know that «ost chronic Lyme Disease can be prevented by early 
detection end treatment. 

The enc Itself Is not controlling disease but Itself Is causing disease. By 
using circular logic to dictate where Lyme Disease nay occur and how It aay be 
dlagnos»d, many people across our nation are being underdiagnosed and under- 
treated for Lyme Disease. Just this last Wednendey, 1 act e teenage girl **«»■ 
Corning, Hew York who hns chronic Lyme Disease, even though she bee been 
tteated with medication for many months. The CDC has declared that Lyme 
Disease le not endemic In Corning, (lew York, so you better not acquire Lyme 
Disease near there because — It can't be Lyme Disease. Well, this young 
women had the nerve to cetch Lyme Disease In Corning, Hew York. She had all 
the symptoms of Lyme Disease for many months. She even had three positive 
serological tests for Lyme Disease, but still her doctor did not treat her. 
Can't get Lyme Disease In Corning, HY. Well, they finally did a aplnal tap 
end guess what, It was positive for Lyme Disease. "Hell, I'll be danged," said 
Laurel to Hardy. "She really docs have Lyme Disease." How, aadly, the young 
women has chronic Lyire Disease because she was not properly diagnosed and 
treated because of disinformation promoted by the CDC. But, really this 
person was lucky. At least she was eventually diagnosed end Is receiving 
treatment, and aaybe someday she will be healthy. God help the person who 

companies who do not wish to recognize Lyoe Olsease as a potentially severe and 
chronic disease because they wish to curtail Insurance benefits, and the CDC hes 
protected the Interests of property over human life because of the potential 
economic consequences that may derive from the knowledge that people ere at rlak 
to encounter a nooetlmes untreatable Illness such as Lyme Disease while en- 
Joying normal outdoor activities In their yards, at the park, or at the beach. 

If yotir llnten to the victims of Lymo Disease, you will hear a message that 
there la a tragedy echoing from every corner of the nation. When the aame 
so called anecdotal stories occur hundreds of times, an open minded peraon 
must take note that perhaps there Is something serious going on. The innocent 
victims of Lyme Disease desperately need eupport froa our government to 
properly attack Lyme Disease. 

Lyme Disease is a poorly undetstood. Insidious Illness creeping serosa the back- 

rarda of our communities, striking Innocent victims of all ages, wreaking havoa 
n the lives of victims and families, being undiagnosed by physicians who rely 
too heavily on poorly controlled, unstandardlzed and unreliable diagnostic 
tests, being untreated by physicians who deny its very existence. In fer too 
many cases, doctors fsll to understand, diagnose, and treat the Illness, and 
they "copout" with asertlons of ratlent psychosis, hypochondria, premenstrual 
syndrome, menopausal syndrome, fibromyalgia and other diagnoses that have far 
less substantiation than a diagnosis of Lyme Disease (which if treated 
correctly end long enough with antibiotics will respond). 

If you can, contemplate the life of a chronic Lyoe Disease victim. Look at the 
world from their point of view. Imagine for yourself. 

"There ere atomic bombs exploding in ay head, and I have bad palne in my kneee. 
I need sen" Ice packs, and then I need some hugs." It's late et night and ay 
son should be asleep, but he has severe headaches that last for 24 hours a day 
for weeks and even months st a time. Headaches are a very personal feeling. 
Bather hard to express to another. One can't say they have a headache that la 
four feet long. But imagine if you may your worst headache, now Imagine the 
headache Is significantly worse, and then imagine it lasting for weeks or 
months. Imagine your head Is going to explode. Imagine that your head hurts 
eo bad that you can't lift It at all so that you Bust lay flat always, except 
to crawl on your stomach to the bathrooa. Hayba you are Imagining a Lyme 
Disease headache. 

It would be bad enough if a headache were the only effect of Lyoe Disease. But 
lt'a only one of many symptoms. Imagine that all of your Joints ache end that 
your neck Is so stiff you don't want to move your body. Imagine ehootlng pains 
moving ell over your body. Imagine your eyes are so sensitive to light that you 
must alt in a darkened room. Imagine you have neurological complications that 
Impair your thlnklnq, your concentration, and your memory. Imagine you were 
young and healthy but now you randomly forget simple facts such aa how to add 
2+2, and you forget names, words, places, directions. Imagine your cardiac 
system gone awry such that your heart rate is 140 when resting and 180 after 
mild activities. Imagine you can't ride your bike or participate in any noraal 
life activities (school, work, and play) because you feel so poorly. Imagine 
you used to wake at the crack of dawn every day eager for activities, but now 
you sleep late and still feel fatigued all of the time. 

Imagine you recover when you receive extended IV antibiotic treatment, and you 
cheer your recovery end stop IV treatment. And then Imagine your crushing 
disappointment when the symptoms return again, whether from relapse or reinfec- 
tion, with the same debilitating and life threatening Impacts. Imagine how you 
would feel after this happened several times. 



26 

Disease poses a slgnflcant health danger to Innocent participants of outdoor 
activities. I request your total and undivided commitment to truly address 
the health needs of the victims of this Illness. I believe congress Bust taks 
firs and decisive action toi 

(1) increase research funds for Lyme Disease* 

(2) Promote prevention of Lyme Disease; 

(3) Promote better methods of diagnosis and treatment! and 

(«) Protect the Insurance rights of ths innocent victlns of chronlo and 
severe Lyme Disease. , 

As you read the remainder of this letter, ask yourself what you would 
reasonable expect from your physician, from the medical community at large, 
from government agencies such as the state legislature, and from Insurance 
companies. Things that come to my mind arei 

(1) Cdrlcern tor the pain and suffering that victims and families experience 
when Lyme Disease becomes chrcnlcj 

(2) Recognition of the severe limitations in the diagnosis and treatment of 
lyme Disease based on present medical knowledge, thereby precluding 
fixed solutions mandated by government bureaucrats or by physicians with 
closed minds about the nature of Lyme Disease and its treatment* 

(3) Recognition cf the need to Increase research to identify mora reliable 
methods of diagnosis and treatment) 

(4) Recognition of the need to Increase education In the public end especially 
in the medical community to be awara of Lyme Disease, to Implement prevent- 
ative measures, and to promote early and effective diagnosis and treatment 
so as to reduce the frequency of this illness and to prevent chronlo Lyma 
Dlscasei and 

(5) Comp-ionlon for the victims of chronic and severe Lyme Disease who most 
need our help, Including access to the best possible treatments, even 

if required for extended periods, with the right to obtain benefits from 
their medical Insurance for this treatment. 

There are some medical researchers who have adopted the dogma that Lyme Disease 
Is always easily treatable vlth a short regimen of antibiotics. This position 
is significantly Incompatible with the real world experiences of real people 
who have suffered greatly for extensive periods of time due to chronic nnd 
pernlstent Lyme Olr.ease. The experience of people across the entire country 
Is unegul vocable I for a certain percentage of people, Lyme Disease Is chronic, 
persistent, debilitating, and even life-threatening. Lyme Disease has multiple 
manifestations, Including cardiac and neurological Impacts. The diverse lmpacta 
of Lyme Disease go far beyond the expertise of rheumatoid arthritis or infec- 
tious disease r.peclallsts. Any researcher or medical doctor who claims to kn 
the definitive answers for Lyme Disease detection and treatment, simply are n 
being open-minded to the diversity of facts and findings about Lyme Disease. 
Far too little Is known about Lyme Disease. The resolution of the mysteries of 
Lyme Disease will require collaboration across many fields of medical expertlsa. 

Th»re are some governement agencies, such as the Center for Disease Control, 
which have not done enough to set the proper tone for an adequate response to 
Lyme Disease. m fact, certain members of thin agency seem more interested In 
suppressing honest debate and disclosure about the true extent and nature of 
Lyme Dlnenne. The CDC has Itself promoted outmoded and erroneous perspectives 
about Lyme Disease, the CDC has systematically suppressed Input from the primary 
physicians who are caring for chronic Lyme Disease victims on the front lines 
of this illnosi, the CDC has attacked the professional Integrity of certain 
physicians who prefer to treat their patients based on their needs rather than 
be surprosed by the CDC, the CDC has practiced favoritism and bias toward a 
small set of medical researchers who are doing the bidding of large Insurance 

liven In Corning, HY or some other so called Mon-endemlc area, or even some- 
body in an endemic area such as anyvhere In Mew Jersey, who contracts Lyma 
Disease, has the symptoms of lyme Disease, has no other Identifiable causa 
for such symptoms, but whose Immune system has the audacity to not elicit 
a positive reaction to serological antibody tests for Lymo Disease. Mever 
mind that many medical studies have demonstrated that immunocomplexea ere 
created by Lyme Disease so that antibodies are not detectable or that Lyme 
Disease sequesters Itself | n brain cells and in human fibroblast cells so 
that it is cutslde the realm of Immune system response. If a person has 
Lyme Disease symptoms but outmoded and problematic serological tests are 
not positive, th"n it can't be Lyme Disease. It must be Disease XXX, which 
can't be treated because It's XXX. Hell what should we expect from the 
Center for Disease Causation? 

On top of all thin, insurance companies ate now misusing the CDC's surveillance 
definition a" the definitive clinical definition for Lyme Disease. Por 
surveillance purposes the CDC definition Is absolutely horrible. And because 
under-reporting Is at epidemic proportions, the CDC surveillance nusbars 
ere totally unreliable. Ten economists con predict the direction of CHP 
better than the CDC can determine how many cases of Lyma Disease may ba 
occurring with what rate of Increase or decrease. 

When the CDC surveillance definition Is misused as a clinical definition by 
Insurance companies, a medical travesty Is put into motion. The practice of 
the art of Medicine Is rendered inoperative and medicine by bureaucratic 
definition is put Into practice. Doctorn are no longer doctors. Cookbooks 
for medicine is all that Is needed. Insurance company bureaucrats In charge of 
profit end loss use the Cookbook for Disease causation to practice medicine 
along with Insurance. (I wouldn't want to be a chicken inside a chlckan coop 
In times like this. ) 



now 
not 



27 




Medical costs for I.ymn Disease should bs controlled byi 

(1) Better research to develop more effective medlclnesi 

(2) The implementation of prevention progtams through tick eradication, 
education, and rhyslclan awareness rrogr.imsi 

(J) The developirent arid availability of more effective diagnostic teats 
which can promote early detection and treatment and morn effective 
and reliable monitoring of rrogrc6s In treatment of the lllnesoi 

(4) negotiated volume discounts for medical nurplles, medicines, and niedlcal 
servlco for long-term treatment of Lyme Disease, via a new partnership 
between hor.pltnls, doctors, and clinics, the medical supply and pharma- 
ceutical companies, and Insurance companies; and 

(5) Any other methods to prevent lyme Disease, to promote early detection, and 
to provide mdre effective medical treatment. 

Hedlcnl costs cannot and nhonld not bo controlled by a mlngul'led effort to 
mandate rationing of medical services on a discriminatory and acl"ctlve basis 
for only the victims of Lyme Disease. Insurance companies should not be per- 
mitted to soil Insurance with long-term hospital or home care benefits, and 
then refuse coverage when a customer requires these benefits as ■ result of 
chronic Lyme Disease. 

Tor Lyme Disease, Insurance companies want to cutoff coverage simply because the 
treatment has an uncertain path to su-cers. If that standard of coverage were 
applied to all Illnesses, there would be many more victims of misguided health- 
care rationing. Are we t" ration healthcare for tuberculosis, diabetes, heart 
disease, AIDs, cencer and every other Ulnese which has an uncertain path to 
resolution. That Is not the way to Improve healthcare In thle country. That 
Is a path to disaster. 

I call upon you for your support In the following matters! 

(1) Stop the biased nttacks by the CDC uron certain members of the medical 
community simply because they do not agree with the CDC. 

(2) Demand that the CDC redefine their surveillance definition tor Lyme 
Disease with Input from physicians most actively Involved In the 
dlegnosle and treatment of Lyme Disease. 

(3) increase research funding for Lyme Disease and direct the CDC and the 
Hilt to ensure that su--h funding is aimed at those truly seeking anwera 
about Lyme Disease (e.g., the Fox Chaoe Institute near Philadelphia) 
rather than thoae who are promoting their pet theories. 

(4) Promote new EPISA guidelines for healthcare benefits such that self- 
insured companies may be reasonably encouraged to provide and aalntaln 
benefits for chronic Illnesses such as Lyme Disease. There ere children 
and adults who need long term treatment to resolve the Impact of Lyme 
Disease. These people were victimised once by a medical community thet 
failed to diagnose and treat their Lyme Disease In a timely end effective 
manner. Don't let Insurance companies or self Insured companies victimize 
the name people a eecond time by denying their medical coverege for long 
term treatment. 

(5) Tromote better prevention, diagnosis, and treatment of Lyme Disease by 
supportingi 

(s) better control of disease vectors via tick control prograae such aa 
thoee promoted by Dr. Terry Schulrer 

(b) education programe for phyalclana to Improve their ability to 
underetend the limitations of current dlagnoetlc teete for Lyaa 

Dlneaset ,_,,., 

(c) education programs for physicians to improve their ability to 
consider and properly diagnose Lyme Disease based on patient symptoma- 
tology; 

(dj more research to understand the in vivo response of Lyaa Dlseaaa 

bacteria to various antibiotic treatments! and 
(a) sore research to develop more tellable diagnostic toola and aora 

effective aedlclnes for Lyaa Dlseaae. 

I look forward to seeing your support for legislation to accomplish the above. 
call ae If you have questions about life Inside a faally with a 
hlld with Lyaa Disease. Thank you for your attention and your support. 

Sincerely, 
, Keith A. Daaa 



Please 



Please call, me it you nave guei 
younq child with Lyaa Disease. 



28 



from: Mrs . Immanuel Kohn 

34 Puritan CL 

Priicetnn. NJ 08540 

609-921 -2309 
to: Committee on Labor and Human Resources 
re: Research needed on Lyme DteeAse 

Please become open-minded re Lyme dteease. It affects different 
victims In different ways. It apes iH sorts of other medical 
problems. Blood tests for It are very Inaccurate. Doctors are too 
Inexperienced In dealing with It and are now erring too often In NOT 
treating it rather than In treating rt 

I am a case In point . In August, 1991, I first experienced 
symptoms. I live In woods fuH of deer. I own two dogs who have 
Lyme and t«ted positive for It My own tests were alt negative. 
Slowly, untreated, I became so ill I turned into an invalid unable to 
work. Top specialists at Mew York Hospital Insisted that because 
of the Wood tests, I did not have Lyme, but that I did suffer from 
other disease or diseases. Ihey ran tests beginning November, 
1991, searching for these other causes of my extreme neurological, 
muscular, sfceJatal etc symptoms. Al tests proved negative. Over 
$20,000 was spent, of which Met Ufa paid over $16,000 I 

Late May, 1993, a urologist found i bladder infection and gave me 
1 ,000 mg of Cipro per day. In five days I was able to function a bit 
In two weeks neurological symptoms had receded so merkedry that I 
actually returned to «fe-walklng around. Thereafter, I waa flnaly 
given a combination of heavy duty antibiotics and am again • 
productive member of eodety. Stifl not what I waa before August, 
1991, -but functioning. As yet I hava not gone off antibiotics. Who 
knows what will then occur ? 

Why wasn't I treated whan I fliat appeared with all the dkilcal 
symptoms 7 T»W*K OF THE MOf €Y MET UFE WOULD HAVE SAVED I 
Think of the pain and suffering and expense I would hava saved. 
Think of how others can be spared a repetition of this . 

PLEASE ACT I 

Ta Committee on Labor and Human Resources 
Re: Lyme heerVig 
From: Emlfy AJrutz 
8 Deen Court 
Cranbury, NJ08512 
609-799-1682 

I am a fifteen year old high school student who has hud ryme disease for six years. 
For five years my motlwr took ma to doctors trying to find out what was wrong. wtth ma. 

I was always a straight A student until It baearne very dfflcurt to concentrate. I had 
memory low, Insomnia, and I was stiff In my bones every morning. Finally, In 
February of 1 902, I waa diagnosed with >yma dlceaaa by Doctor Scottl In Uttle Silver, 
Hew Jersey. It was at that time I became unable to participate In sports. I had been tha 
captain of the chee» lending team and en award-winning member of the swim teem. 

Or. Scotrl gave me oral antibiotics, but they eH not help. I had to do fVs twice After 
seven months of treatment I wes so sick I was unable to attend school I had terrible 
headache*, sore tnroers, joint perns, abd extreme fatigue. Many times I wished I was 
dead because I could not even enjoy going out with my frlanda. 



29 

At this point I started treatment wfch Dr. Blelw a la a !r\ Trenton. MJ. Havana ***** * 
patient with lyme , be understood lyme and how ? fttt. He trotted me for nhe months. 
Attar two and a half months I was able to nstum to school for half day*. After two and • 
half months mora I could go to school «S day. Another two month* and t was back In gym 
class. 

Mow r ve bwi off antlbtotJcs for three month* without symptoms.1 had forgotten what 
it folt rlka to have the aoarory to hang out with frtoodt or wak* up In the morning 
without stiff Joint*. I can now far) a***? at rwjhi because the »bi yean of Insomnia are 
gone. One of the worst parts of having trite d tea aan wm having teachers, dassmatea, and 
even doctors minimizing my suffering. 

I was lucky because my Insurance pasH for my treatment. I heard about a teenager In 
New Jflrsey who recently cHd from lack of treatment, and I thank God that t am aa lucky. 
Please help others to hava the chance I have boon given Co lead a normal Bra. 

Thank you for your tlma . I would lova to fcefc you my story In person. 

Sncerat/, 



fr\Qto§ 



Emily Alrutt 

To: Committee on Labor and Human Resources 

Re: Lyme Hearing 

From: Margaret M. Kohn R.N. 

8 Dean Court 

Cranbury, NJ 08512 
609-799-1882 

Please help with research for diagnosis, treatment, and cure for 
Lyme disease. Grinted, some people ire cured of Lyme disease in 
thirty days. Many are not Three members of my family have been 
struggling with Lyme disease for years. 

My fourteen year old dtughter was bedridden with severe 
neurological and muskoskeJetal symptoms after nirfe months of 
conventional Lyme treatment including two thirty -day I.V. courses 
with Rocephin. I took her to a doctor who treated her with triple 
antibiotics including four months of CflndSffycJrT IV. In two 
months she was able to go back to school, m four months she was 
symptom-free. She has been symptom-free far six months , and off 
antibiotics for three months. 

My husband and I are up and down with symptoms constantly 
adjusting our antibiotics. Wa live in tear of not having access to 
antibiotics , and thus becoming unable to work. We know of several 
lyme deaths In our state . Physicians who treat lyme are being 
harassed by the Medical Board of Examiners. Some doctors are now 
afraid to treat lyme patients because of the current atmosphere. 

Please look Into these matters and heap us to survive! 




73-299 - 93 - 2 



30 

The Chairman. Disease outbreaks over the past several years 
have shown that old diseases such as tuberculosis remain virulent, 
but new diseases continue to appear on an unpredictable basis. 
Some, like toxic shock syndrome, are readily defined and con- 
trolled. Others, like AIDS, seem intractable, in spite of years of 
dedicated work by thousands of health scientists. 

Today we consider Lyme disease, which afflicts thousands of 
Americans. Its continued spread, because of changes in our society 
and our lifestyle, is cause for real concern. 

Lyme disease is named for the place where it was first diag- 
nosed, in Old Lyme, CT in 1975. At that time, the disease was dif- 
ficult to identify, and it was impossible to know how many Ameri- 
cans were afflicted. CDC counted some 500 cases in 1982, and 
nearly 10,000 cases in 1992, a large increase in reported cases. 

Although the disease has been identified in 49 States, it is New 
York, Pennsylvania, and Connecticut that account for the vast ma- 
jority of reported cases. Hot spots of infection occur in some coun- 
ties in California, Connecticut, New Jersey, Wisconsin, New York, 
and Massachusetts. 

Beyond these statistics, however, is the human suffering. Chil- 
dren may be so severely afflicted that they cannot go to school for 
long periods of time. One father of a 12-year-old boy wrote that his 
son "has suffered from severe symptoms of Lyme disease on a near- 
ly continuous basis for 2 years. His symptoms have included severe 
and continuous headache, joint pains, fatigue, neurological deficits 
in memory, disrupted sleep patterns, and many other symptoms. 
He has been unable to participate in normal activities, including 
school, for all of this time." 

Adults can be incapacitated to the point where they can no 
longer work. Healthy people in infected areas are afraid to be out- 
side because of the threat of exposure to the ticks that cause the 
disease. People fear for their children's health and worry about the 
loss of insurance. 

Today we will hear from patients, clinicians, epidemiologists and 
experts from the NIH and the CDC. 

Our first panel will provide perspectives from patients and physi- 
cians, who will discuss the difficulties in diagnosing the disease, 
the devastating health effects, and the difficult dilemmas posed by 
treatment. 

Our second panel consists of epidemiologists who will discuss the 
importance of monitoring the disease, the role of animals in spread- 
ing it, and the effectiveness of our personal protection measures. 

Our final panel, from the CDC and the NIH, will review the Fed- 
eral role in preventing the disease and accurately diagnosing Lyme 
disease and treating it. 

I thank all of the witnesses for their willingness to share their 
experience and expertise and look forward to their testimony. 

The Chairman. The first panel this morning will introduce us to 
the clinical aspects of Lyme disease. The witnesses include Ms. An- 
drea Keane-Myers, a graduate student at Johns Hopkins Univer- 
sity, who has recovered from an acute case of Lyme disease. Mr. 
Carl Brenner was working as a marine geologist when he con- 
tracted Lyme disease and was forced from his job. Ms. Karen 
Forschner is the director of the Lyme Disease Foundation in 



31 

Tolland, CT. Evan White is a victim of Lyme disease, and his 
mother, Ruchana White, will tell Evan's story. 

Well start with Ms. Andrea Keane-Myers. We are grateful for 
your appearance here today. 

STATEMENTS OF ANDREA KEANE-MYERS, RECOVERED LYME 
DISEASE PATB2NT, BALTIMORE, MD; RU CHAN A WHITE AND 
SON, EVAN, LYME DISEASE VICTIM, SUFFERN, NY; CARL 
BRENNER, LYME DISEASE VICTIM, HAWLEY, PA; AND KAREN 
VANDERHOOF- FORSCHNER, DHIECTOR, LYME DISEASE 
FOUNDATION, TOLLAND, CT 

Ms. Keane-Myers. Thank you. 

In the summer of 1989, I contracted Lyme disease. I did not real- 
ize it at the time, but this disease has had an unusual and pro- 
found impact on my life. 

After enduring a summer's worth of discomfort at the mercy of 
a bacterium, I became interested in microbiology and immunology. 
This initial interest has culminated in my working on the immune 
response to Lyme disease for my doctoral thesis in the Department 
of Immunology and Infectious Diseases at Johns Hopkins School of 
Hygiene and Public Health. 

During that summer, I was residing in Salisbury, on the Eastern 
Shore of Maryland. I was on summer break from the University of 
Richmond and was living at home with my parents. To earn money 
for college, I was working two jobs, one as a waitress in a local crab 
restaurant, and the other as a secretary in a doctor's office. By the 
beginning of July, I began to feel fatigued and suffered from recur- 
rent bouts of malaise and headaches. I ascribed these ailments to 
a combination of allergies and to burning the candle at both ends 
with my jobs and busy summer social schedule. 

I also noticed around that time a rather large rash on the back 
of my nght knee, with a red center and lighter ring on the outside. 
It wasn't until much later that I associated the flu-like illness and 
the tell-tale stigmata of Lyme disease, or erythema migrans, and 
assumed the rash was most likely caused by a spider bite. 

I left work one evening at tne end of July because of feeling 
chilled and because my joints were so painful 

The Chairman. You might just slow down a little. It's a very 
moving story, and we want to make sure we all hear it. Thank you. 

Ms. Keane-Myers. Sorry. I left work one evening at the end of 
July because of feeling chilled and because my joints were so pain- 
ful it was becoming difficult to pick up a pitcher of beer, much less 
serve a whole table. I took some aspirin and went to bed and re- 
mained there for a few days, too fatigued and sore to even think 
about moving around. 

The best description I can think of for the misery of acute Lyme 
disease is a combination of debilitating mononucleosis and severe 
arthritis in the knees and elbows. At this time, I noticed more of 
the strange, ring-like rash had appeared on my trunk and lower ex- 
tremities and decided it was past time to visit the family physician. 

Dr. Mary Fleury is our family physician and is an internist prac- 
ticing in Salisbury. My symptoms suggested an almost textbook 
case of Lyme disease, although Dr. Fleury was aware of only one 
other case on the Eastern Shore at that time. 



32 

I did not remember a tick bit preceding the initial rash, but had 
spent some time earlier that summer on Assateague Island. A re- 
cent study done on Assateague had suggested that the majority of 
mammals and Ixodes ticks had contracted the bacteria that causes 
Lyme disease, Borrelia burgdorferi. 

During the initial visit, Dr. Fleury suggested that I get tested for 
Lyme disease and prescribed 10 days of tetracycline. I was tested 
a week after I had begun antibiotic treatment. Not surprisingly, 
the blood test came back negative. Testing procedures tended to be 
poorly standardized at that time and often gave false negative re- 
sults, especially if done after antibiotic treatment had begun. The 
diagnosis was then and is now primarily based upon clinical find- 
ings. 

My condition began to improve with antibiotic treatment, and I 
finished the initial course of antibiotics. However, within a few 
weeks, I began to experience malaise, fever, and migratory arthritis 
again and returned to the doctor's office. She determined that the 
initial treatment was of insufficient duration and prescribed high 
levels of tetracycline, one gram per day, for a month. Once again, 
my symptoms began to recede within a few days of treatment, and 
I finished the course with no further relapses. 

Thankfully, I have not had any further symptoms since the sec- 
ond treatment. However, antibiotic treatment does not always pre- 
vent further complications, so I may still be at risk. I am not 
pleased with the prospect of having to live with chronic Lyme dis- 
ease and sincerely hope better preventive and curative measures 
are developed in trie near future. 

As a result of this experience, I have chosen a career in medical 
science and am currently working on my doctoral thesis at Johns 
Hopkins, studying the immune response to the Lyme disease agent. 
Such information is essential to the formulation of a vaccine. With 
continued funding, I hope this work will move forward and that we 
will soon have a cure for this perplexing and debilitating disease. 

Thank you. 

The Chairman. Thank you. 

I think we'll hear from all the witnesses and then go to ques- 
tions. Ruchana White and Evan, it's nice to see you again. Evan, 
we want to let you know that we're glad to have you here, and we 
enjoyed visiting with you last week; we had a chance to show you 
around the office, and we're glad to have you back. 

Ruchana, if you'd like to, we'd be glad to hear from you next, 
make what comments you might — and I know the lights and so on 
can be bothersome — and then if you and Evan want to remain at 
the table afterward, we'd be glad to have you, but if you feel that 
you'd like to be excused, we'd be more than glad to accommodate 
that. 

Ms. White. I know that Evan has some things to say, but I will 
speak first. 

The Chairman. Fine. 

Ms. White. Thank you, Senator. 

My name is Ruchana White, and I am the mother of Evan White, 
who is suffering from chronic Lyme disease. 

Last week when we were here, and he spoke, he said: "Everybody 
can help when everybody knows. Everybody can get together and 



33 

help. I want help now." Evan can barely speak. He is trying very 
hard. He lost his power of speaking. 

Until September of 1990, Evan was a very popular boy in his 
class, an outstanding athlete, and an excellent student. All of this 
changed, however, when Evan came down with flu-like symptoms. 
Because his area is endemic to Lyme disease, his doctor, among 
many other blood tests, ordered a Lyme test be done. The results 
came back positive. 

Evan was then referred to a pediatrician who specialized in infec- 
tious disease and was started on a treatment of oral antibiotics. 
Evan did not respond well to the medication. He had severe head- 
aches and was unable to raise his head off the pillow. He was given 
the drug Rosephin intravenously for 21 days and as a result, at the 
end, developed gall bladder sludge. 

Evan was referred to a pediatric neurologist, who said that he 
was not medically ill; that his sickness was psychological, despite 
the fact that the original blood tests which snowed that he indeed 
had antibodies to Lyme disease. We obviously were very confused. 
You don't want to be sick when you are 11 years old, on the travel- 
ing soccer team, an excellent lacrosse player, and have many 
girlfriends — who called all the time. 

Evan loved to talk — I have to add this. He never stopped talking 
in all of his 11 years. We would sit in the car, and he would go 
on and on and en. He had so much to say because he had fabulous 
insights into people and life. 

However, we had placed our faith in the doctors and found it dif- 
ficult to question tneir prognosis. We knew that children don't 
want to be sick, and we knew they don't lie, but we were brought 
up in a time when doctors were like gods, and we really felt that 
they were showing us the proper way. 

As a result, they stopped the medication, and Evan began to see 
a psychologist. During the third month of psychological treatment, 
we his parents finally convinced the doctors that his illness was not 
psychological — that his head would fall to his shoulder, and he 
couldn't lift it, it was in such pain. He was beginning to atrophy 
from head to toe, and his hearing had become so sensitive that the 
slightest noise was deafening. A cracker would bother him, or just 
walking into the room. 

We went back to the infectious disease specialist who ran a com- 
plete battery of tests. It was then discovered that Evan's Lyme dis- 
ease had skyrocketed. The doctor said to us: "Oh, my God, he has 
Lyme disease. I don't know what to do." Because there had been 
no treatment during the crucial part of his illness, the disease had 
ravaged his body. The doctors were forced to admit that they did 
not know what to do. The neurologist said he had nothing to say. 

In April of 1991, the doctors placed Evan in a hospital, and he 
was given the drug Clafrin intravenously. He could not walk at 
that time. He would scream due to the severe pain of his head- 
aches, and his speech was beginning to become unclear. His words 
were leaving him; they were broken and shattered, and he couldn't 
get them out. Even spent 2 weeks in intensive care during his 2- 
month stay in the hospital. 

That summer, Evan made many trips to the hospital. He was de- 
hydrated; he couldn't eat anymore, and he had to receive 



34 

nasogastric feedings. He was then sent to a children's specialist 
hospital in Mountainside, NJ. He spent 7 months there. His great 
pain caused him to scream day and night. At this point, we de- 
scribed him as being "completely gone in body and mind." He could 
only recognize his mother and father. His head pain was constant. 

Evan has begun the slow road to recovery. He has attended the 
Helen Hayes Day Hospital for the past year and a half, which is 
very close to our home, and he is able to be with us at 4 o'clock. 
He goes in the morning and comes home at 4 o'clock and is able 
to be with his mother and father, and his brother and sister some- 
times. He receives intensive rehabilitation 5 days a week. He has 
received multiple types of therapy — occupational, physical, speech, 
etc. Whatever can be done for Evan is done at the hospital. We are 
so thankful for Helen Hayes Hospital. 

The results of these painful treatments were evident by February 
1992 — he had strength in his hands again. He had not been able 
to lift a pencil. 

His progress has been very slow, but steady. His legs, arms and 
head are much stronger now. He is able to get around for a few 
moments with the use of a walker. Although he can only speak a 
few words — and this testimony is helping him to get out some 
more, which I am so happy about — his vocal chords have not been 
damaged, nor has any other part of his body — we hope. He is much 
more aware of his surroundings. He has feelings and desires, and 
he wants very much to let the Government know how catastrophic 
this disease has been to his life. He feels that there is a way out 
of everything and that there must be a way out of this as well. 

Obviously, Lyme disease has had a devastating impact on Evan's 
life. Although he was a very popular boy in his class, he no longer 
sees his friends. Classmates continue to call and to send postcards, 
but Evan refuses to see them until he is well and looks good again. 
The trauma of watching Evan suffer has taken a toll on his older 
brother, Daniel, who is in college and who has written a wonderful 
paper about him; and his sister, Nicole, who is currently applying 
to medical school as well as researching Lyme disease herself. 

Fortunately, we have health insurance, because Evan's illness 
has cost us $1 million so far. 

In May of 1993, several months ago, Evan had a brain spec scan 
that showed Lyme encephalopathy throughout, low profusion. It 
was done at Columbia Presbyterian Hospital. The difficulty of diag- 
nosis and treatment is grave, and this is a very big problem that 
we face. 

Evan has lost his education. He can no longer read or write and 
has not attended school in over 3 years. He cannot identify words, 
but sometimes something in a newspaper will jump out at him, and 
he will know what that word says. He knows that everything is 
locked away in the back of his head, but as of yet, he is unable to 
find a way of accessing his knowledge. He says: "Sometimes I feel 
like I am in a bubble, but I can't get out." 

Evan communicates through hand gestures. Frustrated with his 
situation, he is often angry and irritable. He has no appetite. Al- 
though he is 5-foot-4-inches, he weighs only 80 pounds now. He suf- 
fers from insomnia. He enjoys watching television, but without any 
sound; any noise is deafening, even though he wear earplugs and 



35 

headphones. His voice has changed and matured, and "Help" is the 
word he repeats most often. 

Evan is in constant head pain still, and basketball cards are the 
only thing that keep his mind off of his pain. Evan has many ques- 
tions: Why me? Why did this happen to me to make me so sick? 
Why is no one helping me? He is aware that he is losing his child- 
hood. He is now 14 and wants to be a teenager and to play lacrosse 
and soccer and to have friends and to socialize. 

One day, Evan would like to be a psychiatrist and stand-up 
comic — maybe one and the same. He feels that he has plenty of ex- 
periences upon which to draw. He wonders how this is possible 
when he is chronically ill. He desperately wants others to know his 
story so that no more time will be wasted and that a cure will be 
discovered — now. 

My son Daniel says that health is wealth. And all the Lyme dis- 
ease people would like to achieve it. This disease can be dangerous 
and lethal. It is real. It is here. It will strike someone you know. 

Physicians, I plead with you, be open to understanding it, and 
treat your desperately ailing patients. Do not give up on them. 
There are many people across this country like Evan. I hear the 
same story over and over again. 

I thank you. I think you all have this tape, "Kids Speak Out on 
Lyme Disease." Evan speaks for all the children in the United 
States, for the thousands and thousands of children. Please help 
them. 

I thank you. 

Evan. 

The Chairman. Evan, we want you to just relax. This probably 
isn't as much fun as talking, riding in the car, or being at home 
with your family, but we are very grateful to you for being here. 
We had a chance to meet you last week, and we know you are a 
very brave young man. I think you know that your presence here 
is going to help us all try to do something about this. 

So we are very grateful for your taking the time to come today. 
If you have a little something to say, we'd be glad to hear it; what- 
ever your mom thinks is best. I remember last week, when we 
asked you a question or two last week, when your mom asked you 
some questions, you nodded and made it very clear to me what the 
answers were. Maybe she would like to ask trie questions now. 

Ms. White. He'd like to say them. He's been trying. 

The Chairman. That's fine. 

Mr. White. We can't think. We can't sleep. We need you. We 
need everybody to work together to tell everybody how we feel. 

The Chairman. That's very good. Thank you very much. 

Senator Metzenbaum. I'm not sure he's finished. 

Ms. White. If you want to say something else, you can. What 
would you like to say? 

Mr. White. We need everybody to work together to tell how we 
feel. 

Ms. White. Thank you, Evan. 

The Chairman. Evan, we'll hear a lot of testimony, I'm sure, 
today about Lyme disease, but I think those few words of yours will 
be the most powerful. I think you said it all. We all have to work 
together and find ways of making progress. We thank you. You are 



36 

a very brave young man, and it helped a lot to hear from you. I 
think the best way we can thank you is to make sure we do some- 
thing about it like you have asked us to. 

Senator Metzenbaum. Evan, I want to thank you also. I just 
want you to know that we aren't going to let you down. We are 
grateful to you. It takes a lot of courage to come before a Senate 
committee. It means a lot, and your being here is just very, very 
moving and makes all of us more committed to try to be helpful. 

Thank you very, very much. 

The Chairman. I want to thank the mom, too. Your testimony 
was very special. 

Ms. White. Thank you for this opportunity. 

The Chairman. Mr. Brenner. 

Mr. Brenner. Thank you for inviting me to appear here today. 

I used to be a working scientist. In the late summer of 1989, 
while visiting my parents in the Poconos, I took a half-hour rec- 
reational walk through a local field, after which I removed several 
ticks from my arms, legs and torso. 

Several weeks later, I went to Australia on a business trip. While 
there, I had a severe flu-like illness that involved a sore throat, ear 
infection, and the most intense headache and fatigue that I had 
ever experienced. 

I remember feeling a mixture of astonishment and alarm over 
my condition, but I assumed that the fatigue was due at least in 
part to jet lag and the extremely heavy travel schedule that I had 
been on over the previous year. In any case, I seemed to recover 
gradually from the illness over a period of 2 weeks or so and re- 
turned home to Rockland County, NY to resume my normal activi- 
ties. 

Over the next few months, however, it became clear to me that 
something was terribly wrong. I was having bouts of migrating 
joint pain, headaches, irritability, and sleep disturbance. I was ex- 
periencing steadily increasing fatigue. Although these symptoms 
were quite bothersome, I was reasonably functional for a while. 

The first few of the 20-plus physicians I was eventually to con- 
sult all assured me that I was perfectly healthy. None of them ever 
suggested Lyme disease as a possible cause for my complaints, and 
it certainly never occurred to me that I might have it. 

The message from the physicians to me was: This is not really 
happening. You are not really sick. Your symptoms are all in your 
head. 

I was referred to a psychiatrist, whom I willingly consulted, be- 
cause by this time I had become quite depressed by my predica- 
ment and my rapidly diminishing tolerance for any kind of physical 
or mental activity. I was particularly frightened by the fact that I 
was having significant problems with concentration and focus at 
work; I was concerned that I might lose my job. 

I struggled silently with my symptoms for over a year, but by the 
spring of 1991, I felt as if I were nearing some sort of breakdown. 
Sinus surgery was suggested as a possible solution to my persistent 
headaches; it did not work. My symptoms expanded to include 
crushing fatigue and periodic attacks of paralysis on my left side. 
It was clear to me by now that I had some sort of serious illness. 



37 

Nevertheless it was suggested to me on more than one occasion 
that my symptoms were hysterical in nature. 

My psychiatrist, on the other hand, had become convinced that 
I was in fact suffering from Lyme disease and at his suggestion, 
I had begun to read up on it. 

In July of 1981, I had a consultation with an infectious disease 
specialist and a rheumatologist at a major university hospital, dur- 
ing which I asked about the possibility of my having Lyme disease. 
I was told that my symptoms sounded "completely unlike" Lyme 
disease, I was offered antidepressants, this despite the fact that 
neuropsychiatric evaluation snowed that I had organic deficits in 
memory recall tasks, a common manifestation of late Lyme disease, 
and no underlying personality or mood disorder. Once again, de- 
spite evidence to the contrary, the messages was: This is not really 
happening to you. The problem is all in your head. 

I was finally diagnosed with Lyme disease in August 1991, 2 
years after the onset of my illness. I was treated with oral and 
then intravenous antibiotics for a total of almost 6 months. In Au- 
gust of 1992, still severely symptomatic after having been off treat- 
ment for 6 months, my urine was probed for spirochetal DNA via 
the polymerase chain reaction. The results came back positive, in- 
dicating active infection. Follow-up assays performed on both urine 
and spinal fluid were also positive. 

I was hospitalized and put back on intravenous antibiotics in Oc- 
tober of last year, during which I had a classic Jarisch-Herxheimer 
reaction — also an indication of active infection — marked by fevers 
and a radical worsening of my arthritic symptoms. The treatment 
was unsuccessful. Over the past winter, I was completely crippled, 
unable to even stand in the shower. While the arthritis later 
abated somewhat with further treatment, I am now unable to ei- 
ther work or look after my daily needs, and have been living with 
my parents since last autumn. 

I am deeply uncomfortable with my assigned role today of "des- 
ignated Lyme victim," but I have lost almost everything of value 
in my life to this disease — my career, my mobility, and worst of all, 
my autonomy. And there are many Lyme patients, as you well 
know by now, who are worse off than I — people cleaned out finan- 
cially, uninsured, and unemployable, children in wheelchairs. 

Over the last year, I have talked on the phone with a wheelchair- 
bound former special education teacher from Westchester who con- 
tracted Lyme disease on a class outing and who now suffers from 
a horrendous seizure disorder. These calls have now ceased because 
she can no longer speak. 

Another Westchester woman, also disabled, had the Lyme spiro- 
chete cultured from her spinal fluid after many months of high-dos- 
age antibiotic therapy. Both of these women were told repeatedly 
that their symptoms were psychosomatic and not attributable to 
borrelial infection. "This is not really happening to you. It is all in 
your head." 

I have been asked by the committee to comment on how Lyme 
disease has influenced my career path. I don't know what to say, 
other than it has destroyed it. Before my illness, I was a marine 
geologist at Columbia University, involved in research and science 
management on an international level. I hadn't taken a sick day 



38 

for years. I had some contacts in Washington and was hoping even- 
tually to come here as a Senate staffer on science matters — per- 
haps I might even have worked for one of you. And I am really glad 
that Senators Metzenbaum and Kassebaum came in, so I could say 
that and mean it, because there was only one Senator here before 
that. 

Instead, I am now drawing disability. You ask about the experi- 
ence of being a chronic Lyme patient. To be a chronic Lyme patient 
is to be caught in a Catch-22. There seems to be no incentive for 
anyone to acknowledge that we exist. The entrenched institutional 
denial of both the scope and intractability of chronic Lyme disease 
has devastating effects and shows no signs of abating. It causes 
delays in diagnosis, which often allow an acute illness to become 
chronic, as it did in my case. It limits access to antibiotic therapy 
at all stages of the disease. 

The researchers note the persistence of symptoms after treat- 
ment, but do not admit that their treatment recommendations are 
often inadequate. 

The insurance companies, who don't want to pay for longer-term 
treatment, hire these same researchers as consultants, who predict- 
ably say that we are "cured," despite ongoing symptomatology and 
considerable scientific literature documenting the persistence of the 
bacterium after treatment. 

Meanwhile, NIH allocates virtually no resources at all to re- 
search on chronic Lyme. 

I am a scientist by vocation and a skeptic by nature, but I am 
here today to tell you that this happening, that we are real, and 
that I am not some rare, anomalous case that slipped through the 
cracks. Lyme disease has already destroyed the lives of thousands 
of productive Americans, with untold thousands more persistently 
infected and standing on a precipice. 

Finally, the many controversies surrounding Lyme disease and 
due in part, at least, to the lack of hard data that can be applied 
at the individual patient level. As a result, discussion on the preva- 
lence of persistent infection has generated largely into a game of 
"dueling anecdotes." The existence of new direct detection tech- 
niques now gives researchers the opportunity to explore this ques- 
tion in a systematic fashion. Please urge NIH to focus its funding 
efforts on the etiology of chronic Lyme disease with an eye toward 
developing a permanent cure for this affliction. 

Thank you. 

The Chairman. Thank you very much. 

Senator Bradley is here, and well hear from him now. 

STATEMENT OF HON. BILL BRADLEY, A UJS. SENATOR FROM 

THE STATE OF NEW JERSEY 

Senator Bradley. Mr. Chairman, let me say first how much I, 
like you, appreciate this panel's presence here today and their will- 
ingness to share some of their own personal pain with the commit- 
tee, in the expectation that it will actually make a difference in the 
lives of thousands of other Lyme patients who are out there in our 
country today, struggling with this disease in ways that are hard 
for us to imagine. 



39 

Lyme disease is one of the fastest growing infectious diseases in 
America; only AIDS is faster. And some of the stories that you 
have heard today illustrate the problem, and that is that the pa- 
tients are denied what they feel and what they know. They have 
doctors who tell them they are not sick; they have treatments that 
they are told will solve the problem, and it doesn't solve the prob- 
lem; they struggle with fear. And others who experience their lives 
have that fear expanded and intensified. 

Since 1982 in my State of New Jersey, there have been over 
4,000 reported cases of Lyme disease — 4,000. And those are only 
the cases that have been reported. I shudder to think about how 
many more there are that have gone unreported or undiagnosed. 
I have spoken with countless constituents who have suffered 
from this disease, some for years, struggling each day to battle 
back from an affliction with the hope that maybe we'll start to do 
a better job with it. 

At a town meeting during the July 4th recess, one woman came 
to that town meeting in a wheelchair, unable to move because of 
Lyme disease with a child who also had Lyme disease. This is an 
enormous national problem that we are refusing to address. 

I think this hearing could be of enormous historic importance 
simply because at least there is now a body that is looking at this 
with the seriousness that it deserves. 

Mr. Chairman, that is one of the reasons that I cosponsored the 
joint resolution establishing Lyme Disease Awareness Week. That 
is just the beginning. NIH has to get its act together as well. 

You will later hear from the medical community. But make no 
mistake about it. This is where AIDS was in the mid to late seven- 
ties in awareness, and it is a much more pervasive illness. 

I live in a section of New Jersey that is wooded, and when I walk 
in the woods I am constantly looking for the tick, thinking that the 
tick might have bitten me. In New Jersey, we have the highest con- 
centration of deer anyplace in America. Nobody realizes that. Deer 
are suburban rats in New Jersey, and they carry the tick. Thou- 
sands of my constituents, when they walk, believe they are taking 
a risk, and so they don't walk. 

I hope that this committee will deal with this disease with the 
seriousness that I think it deserves. I hope well double our efforts 
so that we will get accurate diagnosis and adequate treatment for 
this disease. It is an enormous problem. 

Mr. Chairman, I want to thank you for allowing me to come, and 
thank the panel for allowing me to make my statement in the mid- 
dle of their stories, which are much more moving than any politi- 
cian's statement. But I think that I am speaking for literally thou- 
sands of my constituents who are afflicted and tens of thousands 
more who are afraid of a walk in the woods. Many of them were 
here at the time last week when this hearing was scheduled; they 
could not come back for this hearing. 

But Mr. Chairman, I want to thank you for making the effort to 
specifically speak to the hundreds who came the last time, to reas- 
sure them of your interest in this and the committee's interest in 
this. That made a difference. 

I believe the committee can make a difference, and the Senate 
must make a difference. 



40 

Thank you very much. 

The Chairman. Thank you very much, Senator Bradley, for tak- 
ing the time to give that very compelling statement about your 
strong interest and desire and support for action. 

Karen Forschner, we'd be glad to hear from you now. 

Senator Dodd. Mr. Chairman, Karen is from Connecticut. I want 
to welcome her and thank her for coming to Washington twice in 
1 week. I also thank the chairman very, very much for holding this 
hearing. 

Mr. Chairman, we in Connecticut are proud of many things in 
our State, but the fact that this disease is named for a couple of 
Connecticut towns is something we are not terribly proud of. 

In fact, Mr. Chairman, you may recall a few years ago when you 
were visiting the State, you took a beautiful ride on a road called 
Joshua Town Road, and you described it to me as one of the 
prettiest roads you had been on in New England. That road runs 
right through Lyme, CT, which is the town where this disease got 
its name. 

We are one of three States that account for a majority of the 
cases in the country. We also have the highest reported rate of 
Lyme disease among all States, at 54 cases per 100,000 people. 
This figure is low due to under-reporting, but those are the num- 
bers we are given. In the Lyme, CT area, the rate is more than 500 
per 100,000 people. So it is a staggering problem in our State. 

I am pleased, Mr. Chairman, that Dr. Matthew Cartter, Con- 
necticut's epidemiology program coordinator in charge of Lyme dis- 
ease, will also be here this morning to discuss the situation in Con- 
necticut and our efforts to prevent and control the disease. As I 
have mentioned, the disease is of particular concern to me because 
it affects Connecticut as a whole; however, I think it is also impor- 
tant that we recognize and hear from individuals who suffer from 
the disease, and the witness you are about to hear from, Karen 
Forschner, of Tolland, understands this disease in a very poignant 
way because of what has happened to her own family; her son lost 
his life and she herself has suffered. Karen has been a leader on 
the issue, and I think you'll be moved by what she has to say. 

Mr. Chairman, there are obviously many aspects of the disease 
that are unknown and troublesome. First, there are few answers 
to the health problems of people who continue to suffer from the 
disease even after therapy. And there is no effective test to diag- 
nose Lyme disease. 

At a time when we must worry about the safety of our children 
on the streets and even in the schoolyard, it is disturbing that we 
must also be concerned that playing in the back yard may pose a 
serious hazard to our children. But we must be concerned because 
the absence of an effective test means that some parents won't 
know whether their children have Lyme disease until they get sick. 
If we had a vaccine against Lyme disease, we would have one less 
worry about their health and safety. 

I agree with Senator Bradley. I think this hearing is extremely 
important. I commend you for holding it, and my colleagues here 
for attending this morning. 



41 

And I am very pleased and honored, Karen, that you are here. 
Again, we all apologize for what happened last week, unavoidably, 
but we are deeply grateful to you for being here today. 

Thank you, Mr. Chairman. 

The Chairman. Thank you very much. 

Karen. 

Ms. Forschner. You mentioned that I chair the board of direc- 
tors of the Lyme Disease Foundation, but after all my years of a 
career, I find that my most important role that I have ever had was 
as Jamie's mom, and that's the role I will speak about today. 

The other thing I'd like you to remember is that the people who 
are here on the panel are not the people speaking because of woe 
is us, and an example for fun drai sing to get more money from the 
Government. We are an example of what has happened when the 
Government system let us fall through the cracks. And the heroes 
of this disease are within the Government, within Congress. But 
also the main heroes of this disease are the public, the people who 
are sitting behind me and the people across the country who have 
taken the message and the advocacy to everybody they can, and as 
I think you know, from some of your faxes and letters, they have 
also taken the cause to you. And we thank you for having this 
meeting today. 

The cancellation last week indeed was a very honorable thing for 
you to do, Senator Kennedy, because it gave everybody a chance to 
nave input into the process, and I thought it was very nice. 

I will talk as fast as I can, because I know you are 

The Chairman. No, no. Take your time. We have the time. 

Ms. Forschner. I am glad, because I'm 5 months pregnant, and 
I'm a little bit breathless right now. 

The Chairman. That's allright. Take your time. 

Ms. Forschner. In 1985, our only child was born. Unfortunately, 
I had a bug bite and the full range of Lyme disease symptoms 
while I was pregnant. Soon after Jamie's birth, his symptoms start- 
ed. During the pregnancy and after the birth, I was seriously ill 
with multiple problems, including joint swelling and pain. Shortly 
after giving birth, a doctor told me that my crippling pain was ar- 
thritis and a permanent condition, and that he expected me to re- 
main on crutches until I required a wheelchair. 

However, there was this mystery illness called Lyme disease, and 
the doctor offered me 2 weeks of antibiotics, just in case. If my 
symptoms went away, and I was cured, I had Lyme disease; if my 
symptoms remained, I did not, and I would be wheelchair-bound 
for the rest of my life. 

At the same time, all five of our beloved pets, three cats and two 
dogs, became seriously ill and required repeated hospitalizations. 
As fate would have it, all of us had contracted Lyme disease at the 
same location and time. Eventually, all of our pets were lost due 
to their Lyme disease. 

Jamie was the light of our life. He had blond hair, blue eyes, and 
was always smiling. By the time he was 6 weeks old, his health 
was in question. He had repeated vomiting and eye tremors. By 6 
months old, he was showing signs of brain damage, eye problems, 
possible deafness and had ceased to grow properly due to malnutri- 
tion. 



42 

I questioned the doctors about whether my son could get Lyme 
from me during pregnancy, and they guaranteed me absolutely no. 

To understand this disease and how it affected our family, I 
would like to tell you what it did to our son's brain. The bacteria 
attacked the part of his brain that controlled his eye movements, 
causing his eyes to swing rapidly back and forth, to turn inward 
at times and outward at other times. And he became light-sen- 
sitive, which caused double vision, motion sickness, inability to 
open his eyes outside, and blindness. 

Jamie's facial and tongue muscles were also involved, causing his 
face to be partially paralyzed and droop, which is like a Bell's 
palsy, resulting in excessive drooling, loss of speech, loss of the 
ability to eat or swallow, and allowed food or saliva to go directly 
into his lungs instead of into his stomach. 

Children and adults started staring at him. The loss of speech 
frightened him. Feeding him by mouth became life-threatening as 
repeated lung infections set in, and eventually a partially collapsed 
lung resulted in multiple hospital stays. Jamie could not tell us 
that he was scared, that he had a headache, that he was hungry, 
or that he needed to go to the bathroom. Jamie became mute, mal- 
nourished and frustrated. His hearing was affected, causing the 
hearing test to show another blow to us, that he was profoundly 
deaf. It was only then when his speech started that we realized the 
test was wrong and had been influenced by the damage done by 
the Lyme disease bacteria. He indeed wasn't deaf. 

Jamie's stomach was involved, causing repeated vomiting. And 
since he was too weak to lift his head, we had to worry that he was 
going to drown. 

Jamie's nerve conduction was affected, which delayed the innova- 
tion to the muscles; this caused him to lose muscle tone, and he 
became "floppy." This meant that he could not sit, crawl, or hold 
his head up, and he certainly could not feed himself. 

The devastating set of involvements that are known to be Lyme 
disease involvements made Jamie 100 percent dependent — for life. 

Tests, probes, biopsies, all could not pinpoint the problem. When 
Jamie was 1-1/2, he had surgery to realign his stomach in an at- 
tempt to stop the life-threatening vomiting. The surgery did not 
work, and our son had a permanent hole cut in his stomach so that 
he could feed through a feed tube. Indeed, we really only needed 
antibiotics. 

Tom's company, a CPA firm, declared that Tom no longer had 
that "zip" that they expected of their potential partners, and pro- 
ceeded to let Tom go. Today, the family leave bill would have pro- 
tected him and given him time to set his home life more in place. 

As Jamie approached his 2nd birthday, we found ourselves un- 
able to provide the medical care needed, and we were told to insti- 
tutionalize him or put him up for adoption, as there are families 
who are set up to handle multiple-handicap children. 

I turned into our son's advocate, no longer listened to what the 
doctors said, and started searching the medical literature. And I re- 
alized Jamie had Lyme disease, I had Lyme disease, our pets had 
Lyme disease — and transplacental transmission had already been 
published. We fell through somebody's cracks. 



43 

Then a doctor saw permanent damage in our son's eyes, damage 
caused by congenital infection— one just like Lyme disease. We 
tested positive. We were told we would be cured. We got some 
treatment, and my life was good. 

Unfortunately, it wasn't quite true, and our son relapsed. The 
meningitis in his brain had caused his head to enlarge to the size 
of a 14-year-old. His clothes no longer fit. We had to get specially 
adapted clothing. As a little boy, the head still has room to grow 
larger when there is a lot of pressure, and the only time we had 
to worry was when his head stopped having that ability to enlarge. 

When his relapses were in process, his throat would collapse, and 
he would spend time on life support. Indeed, our lives were a mess. 
Media people saw this child as a great example for some sort of lit- 
tle TV blurb and soundbite. Indeed, I think that what we saw was 
a child who was courageous and might indeed help other people 
learn a little bit about this disease — and maybe, God forbid, yes, 
maybe he might be able to get some funding for the Government 
so there would be answers before he would die. 

Indeed, when I saw what was happening when Dan Rather had 
him on television and showed the story not of what I saw was a 
courageous story, like the courageous stories here, but all of a sud- 
den a story of what was termed "every parent's worst nightmare." 
Indeed, he wasn't the worst nightmare, and we hadn't gone 
through the worst nightmare yet. 

Those words will always haunt me. And then, the nightmare 
began. Indeed, over time, he was on life support many times, and 
when he received treatment, he would recover. His vision returned. 
His speech started. He started to feed by mouth. The vomiting 
stopped. He gained weight. His lips could kiss, and his arms could 
hug. But despite the dramatic ana documented improvements, over 
the years, local doctors and health officials would interfere repeat- 
edly with our son's retreatment. Indeed, it was an obsession to 
make sure that our little boy did not get treated because it was 
curable, and you didn't need to treat more than 4 weeks. 

After attending a medical conference, I realized much informa- 
tion about Lyme disease was not reaching the medical community 
nor the public. Only limited information that was acceptable was 
reaching them. And with the help of researchers, business people, 
lay people across the country, we established the first organization 
dedicated to Lyme disease. 

Our mission was to provide an area where scientific information 
could be discussed — all areas, all avenues, not just one or the sta- 
tus quo, but what exactly is out there, known, that we can get to 
the truth with? 

I gave up my career and spent 70 hours a week for the last 5 
years to volunteer at this organization. The sacrifices were great, 
as many people in the audience know. We used up our life savings 
in the process. We had no money left. Our parents provided us with 
food and clothing; Santa Claus didn't come unless my mom and dad 
bought the presents. We were in a race against time. Within 2 
years, we had reached 210 million people across the country, and 
Lyme disease had become a household word — not because of two or 
three of us, or because the Lyme Disease Foundation, but indeed 
because of the public. 



44 

Much of this effort was due to this massive grassroots education. 
And indeed, I must say Senator Lieberman helped greatly, as did 
other Senators and Congressmen who then decided to set up Lyme 
Awareness vVeek. 

In 1990, NIH's new test that they had developed, which is not 
available to the public yet, photographed the bacteria in my son de- 
spite his repeated treatment, and not only him, but other people 
across the country, showing that short-term treatment for a few 
people may not ever work and may not work at all. I was dis- 
mayed. When I showed this to the pediatricians, they said if we re- 
treated our son, based on what they got from our local health de- 
partment and our local people in the State, they would cancel us, 
and they canceled my son as a patient. We had no physician in the 
State, so we took our son to New Jersey. 

Once he was retreated, all his speech came back again, and for 
the third time, he learned how to speak. Muscle tone came back, 
vision came back; indeed, they were able to show his intelligence 
was very high. He was mainstreamed into kindergarten. He devel- 
oped girlfriends, went to birthday parties, and we finally found a 
little boy inside the diseased body. 

We waited over 1 year for NIH's test to be released. We were 
hoping we could use it to check on our son's progress so that he 
would not have a relapse and die. As my son started to relapse, I 
waited and waited, and I waited too long. 

Our son's last relapse came on, and he started having seizures 
and brain infections. Within 24 hours, he was dead. His Drain had 
swelled up so much it had killed itself. There was no tissue bank 
in the country to send his autopsy remains to, so before I went 
down to see him and make arrangements, I picked up the phone 
and called around the country and found some places that could 
take the tissue and study it. One of those places was indeed the 
same place where we couldn't find the test, at Rocky Mountain Lab 
at NIH. And indeed, please remember that name, because those 
people are wonderful, and they need your funding more than any 
other area. 

They took his tissue, as well as some other places in the country, 
and were able to document that when he died, he was still infected 
with Lyme disease bacteria. And at some point, his report, com- 
bined with other deaths due to Lyme disease, combined with other 
children with transplacental information, may indeed at some time 
in the future have enough peer review publications that the CDC 
may indeed accept transplacental transmission or death due to 
Lyme, in which case public health policy can be improved. 

Insurance limits for us were used up at $2 million. The final 
total cost to society for our son was that amount. We all paid the 
price through insurance premiums, Government, policy, and the 
like. 

If public policy were prevention-oriented instead of antibiotic- 
hysterical, trying to prevent people from getting treated, my son 
would have been treated much sooner, and I would have been 
treated, and so would the people here have been treated. A society 
that waits for disease to happen and hopes like hell we can eaten 
up is not the type of society we want for the future. Our public pol- 
icy must dictate strong prevention programs. 



45 

Thousands of us have worked toward finding the truth about this 
disease. We are hoping that the Government will move forward, 
past its status quo-seeking behavior. We are not asking what the 
country can do for us; we are asking what the country can do with 
us, and what you will stop preventing us from trying to do with 
you. 

We have worked for over 5 years, we and people in the audience, 
all together, most of the time, and find it is now time for a change. 
We are asking for your leadership. I hope that by the time the baby 
I am carrying is born, there will be some effective, coordinated pro- 
gram in the Government that can help prevent any other children 
or adults from getting this disease. 

Remember, all of your States have the tick now, and all of your 
constituents can get this, and your grandchildren, and your uncles 
and aunts and nieces could get this disease. 

I would like to close by saying one thing, to let you know that 
we received a grant as of 2 years ago from the CDC for public edu- 
cation, and wound up producing a bilingual educational video that 
went out to 9,000 schools. As of this spring, over 3.5 million chil- 
dren have directly seen this video on Lyme disease and remember 
it, because of the partnership between ourselves — I am pointing to 
Duane Gubler— and the CDC. 

I thank you for this chance to talk, and I hope that you will take 
this into consideration. Thank you. 

[The prepared statement of Ms. Forschner follows:] 

Prepared Statement of Karen Vanderhoof-Forschner, BS, MBA, CPCU, CLU 

In 1985 our only child, Jamie, was born. Unfortunately, I had a bug-bite and the 
full range of Lyme disease symptoms while I was pregnant and soon after my James 
birth, his symptoms started. During the pregnancy and after the birth I was seri- 
ously ill with multiple problems including serious joint swelling & pain. Shortly 
after giving birth, a doctor told me my crippling arthritis was a permanent condition 
and I would remain on crutches until I required a wheelchair. However, there was 
this mystery illness called Lyme arthritis and the doctor offered me 2 weeks of anti- 
biotics—just in case. If my symptoms went away, had Lyme. My symptoms tempo- 
rarily improved and once off treatment the symptoms came back — in full force. 

At the same time all 5 of our beloved pets, 3 cats &. 2 show dogs became seriously 
ill after multiple tick bites and required repeated hospitalizations. As fate would 
have it, all of us contracted Lyme Disease. Eventually all my pets were lost due to 
Lyme Disease. . 

Jamie was the light of our life, blond haired, blue eyed and smiling. By the time 
he was 6 weeks old his health was in question. He had repeated vomiting and eye 
tremors. By 6 months old he was showing signs of brain damage, eye problems, pos- 
sible deafness and had ceased to grow properly due to malnutrition. I questioned 
the doctors about whether my son could get Lyme from me during pregnancy. I was 

guaranteed he couldn't. Our son was never exposed to ticks and never had a tick 
ite. 

To understand this disease I would like to explain what it did to our son s brain. 
The bacteria attacked the part of his brain that controlled: 

— Jamie's eye movements, causing his eyes to swing back & forth, turn inward 
& outward, and become light sensitive. This caused him to have double vision, mo- 
tion sickness, inability to open his eyes outdoors, and blindness. 

— Jamie's facial & tongue muscles, causing his face to be partially & sometimes 
fully paralyzed & droop resulting in drooling, loss of speech, loss of the ability to 
eat or swallow, and allowed food or saliva to go directly to his lungs. Children & 
adults started staring at him, loss of speech frightened him, feeding nim by mouth 
became life threatening as repeated lung infections started & eventually a partially 
collapsed lung resulted in multiple hospital stays. Jamie could not tell us he was 
scared, had a headache, or even that he needed the bathroom. Jamie became mute, 
malnourished, and frustrated. 



46 

Jamie's hearing, causing his hearing test to show he was totally deaf. Then 
Jamie started talking. The I^yme Disease nerve involvement had affected the test. 
Unfortunately, we were unable to tell how It affected Jamie's hearing. 

— Jamie's stomach, causing repeated vomiting and since he was too weak to lift 
his head and we had to worry about his drowning during times he was laying down. 

—Jamie's nerve conduction causing loss of muscle tone. Jamie was "floppy", and 
couldn't sit, crawl, feed himself or even hold his head up. 

This devastating set of involvements made Jamie 100 percent dependent — for 
life. 

Tests, probes, biopsies, all could not pinpoint the problem. When Jamie was IV2 
he had surgery to realign his stomach in an attempt to stop his life threatening 
vomiting. The surgery dBdnt work and our son had a permanent hole cut Into his 
stomach so he could have a feeding tube installed to help keep him alive. 

Tom's company, a CPA firm, declared Tom (my husband) didn't have that "zip" 
that potential partners needed and proceeded to let Tom go. Today, family leave 
would have given him some time to take care of his devastating family life. 

As Jamie approached his second birthday we found ourselves unable to provide 
the medical care Jamie needed and were told to institutionalize him. I turned into 
my sons advocate and spent several months researching the medical literature. I re- 
alized Jamie had Lyme Disease contracted through placental transmission. Trans- 
mission of infection during pregnancy and adverse outcome had been already docu- 
mented in medical literature. 

Then, a doctor saw permanent damage in our son's eyes — damage caused by of 
a congenital spirochetal infection. Indeed, we discovered Lyme Disease was caused 
by a spirochetal bacterium. Then, I found a test for Lyme Disease resulting in Jamie 
and I testing positive! All of my sons symptoms were explained by the medical lit- 
erature on Lyme Disease. Life was good. I was told my son would get treated and 
the disease process would stop. Lyme was easily curable. Not true. Jamie was treat- 
ed and relapsed — several times. The meningitis in his brain had caused his head 
to enlarge to the size of a 14 year old. Clothes didn't fit unless adapted "for the 
multihandicapped". Howl learned to hate that word. When Jamie's relapses were in 
process even nis throat would collapse and he spent time on life support. Media peo- 
ple were rushing out to see this child. I thought Jamie's story was of courageous 
struggle, but, Dan Rather termed it the Way the media saw the story as "every par- 
ents worst nightmare". Those words will always haunt me. And, then the nightmare 
started. 

Indeed, over time he was on life support many times. When Jamie received treat- 
ment he would recover. His vision returned. His speech started. He started to feed 
by mouth, his vomiting stopped. He gained weight. His lips could kiss and his arms 
could hug. But, despite the dramatic & documented improvements, over the years 
local doctors and health officials would interfere repeatedly with our son's 
retreatment — as Lyme was easily curable. Despite the proved cause & effect of 
treatment, evaluated by many independent professionals, the label of "Lyme Dis- 
ease" caused a paranoia behavior to withhold life-saving treatment. When we asked 
the pediatrician for Amoxicillin to give to our son over a 3 month period to prevent 
a relapse we were told that Amoxicillin was dangerous and there was no proof the 
Lyme bacteria can survive the short-term intravenous medicine he had while on life 
support. Two weeks later we were back to the pediatrician for a potential ear Infec- 
tion. The same pediatrician prescribed the now "safe" antibiotic Amoxicillin to pre- 
vent an ear infection that had not yet started. And, the prescription was issued in 
the same dose we had requested for a total of 4 months. 

After attending a medical conference, I realized much information about Lyme 
Disease was not reaching the medical community nor the public. And, with the help 
of many researchers, business, & laypeople established the first organization dedi- 
cated to Lyme Disease — the Lyme Disease Foundation. Our mission was to provide 
an area where all of the scientific information could be discussed, not iust the U.S. 
version of "status quo". Igave up my career and spent 70 hours a week for the last 
5 years as a volunteer. The sacrifices were great. We used up our life's savings in 
the process. Family provided us with food, clothing, holiday gifts for our son, and 
much support. We were in a race against time. Within 2 years we had reached 210 
million people and Lyme Disease became a household word. Yet, there were no an- 
swers for our son. 

Doctors started fighting about whether or not my son should be retreated— even 
doctors not involved In my sons care! Yet, there was proof that Jamie's persistent 
infection continued to ravage his body. Electron microscope pictures of the Lyme 
bacterium proving current infection were not enough "proof" for the pediatricians. 
After all, they had talked to the State health department and even an academic who 
recommend no retreatment. 



47 

In 1990, NETs new test photographed the bacteria still In my son, despite re- 
peated treatment, I was dismayed. When showed this to his pediatricians the doc- 
tors canceled my handicapped son as a patient since I planned to have him re- 
treated because he was heading into another serious relapse. Once Jamie was re- 
treated he gained back speech, muscle tone, vision, eating and many other little boy 
skills. He was finally mainstreamed, after 2 years of "advocating", into kinder- 
garten. You see, once you are ill there are many battles to wage. Jamie developed 
girlfriends, learned to operate an electric wheelchair, became "potty trained" and we 
finally found the little boy inside the diseased body. 

We waited over 1 year for the NIH test to be released and available to check our 
son's progress. As my son started to relapse again, I waited for the NIH test, it was 
always close to being run. It never came and we waited too long. 

Our son's last relapse came on and he started having seizures from the brain in- 
flammation. Within 24 hours he was put on life support. The day he was declared 
"out of the woods", he died. His brain swelled up so much it killed itself. There was 
no tissue bank to send his autopsy remains to, so I had the unpleasant task of call- 
ing researchers around the country and dividing up my sons body to sent to dif- 
ferent researchers. I loved this little boy and would have died for him and, here was 
forced to arrange an autopsy. You see the CDC has been denying congenital Lyme 
and death due to Lyme, despite numerous publications to the contrary and I hoped 
this would prove it in order to help other children. 

Insurance limits were used up, Jamie's medical bills totaled about 2 million dol- 
lars. The final total cost to society for our son was around 21/2 million dollars. The 
majority of the cost was in disability care and excessive nonLyme Disease testing. 
A minor amount was in treatment with antibiotics. 

And, yes, the autopsy proved Lyme Disease bacteria were still in his brain. Our 
lifetime of savings were gone. Our pets were gone Our jobs were gone. Our baby 
was gone. 

If public policy was prevention oriented instead of anti-antibiotic hysteria oriented 
my son would be alive today. I am not alone. Other mothers have also lost their 
children. 

Thousands of us have worked toward finding the truth about this disease. Unfor- 
tunately, some parts of the government have an obsession with keeping the status 
quo. The true hero's of Lyme Disease have been a wide mixture of public, support 
groups, researchers, some academics, front-line physicians and some members of 
congress. HHS has proved to be a failure in coping with emerging epidemics and 
Lyme disease patients are one more casualty from the current ineffective health 
care system. 

We have not asked what the country can do for us, we have always tried working 
with the government. We are now demanding the government become responsive to 
the public's needs. I think this disease may not be easy to diagnose, easy to treat, 
nor easy to cure. And, sometimes permanent damage may occur. There may even 
be deaths due to Lyme Disease. We have tried the old ways for over 5 years, it Is 
now time for a change! 

The Chairman. Ms. Forschner, we thank you, not just for your 
words, but for your real life commitment and what you have been 
doing and what you continue to do. It is an extraordinary example 
of a mother's love for a child, going to the extent that you did 
under the most extraordinarily difficult and trying circumstances. 
You have demonstrated that and clearly extended it not just to 
your own child, but to others, and that's really the ultimate act of 
both faith and love, and I think you are a real inspiration, as are 
the others who have testified here, for us here today. 

You mentioned the family leave legislation, and we have our 
good friend Senator Dodd to thank for that. This is the first day 
of its implementation, and I think you gave us a very good example 
of why that legislation is important, as just a sidelight on this. 

This panel really reminds us of the importance of diagnosis. I 
had a son who had a tumor inside his spinal column, and we went 
for a number of months where they said it was psychosomatic. 
They examined x-rays and blood and couldn't find it, and then fi- 
nally moved the MRI up two notches after he had lost all balance 



48 

and found it. And the first thing he said after 12 hours of surgery 
was: "I'm so glad people don't think I'm a faker." 

The indignity that you had to endure over all this time when 
people said it's something in your mindset — not that in and of itself 
is wrong; people have mental challenges and needs and difficulties, 
but just the sense that you have that you know that it is something 
else and the frustrations that you had in not being able to get at- 
tention is something that I think is so powerful in terms of diag- 
nosis and what we nave to do to be able to come to grips with it. 
That is a challenge of education in the medical profession; it is try- 
ing to work with scientists and researchers to find the best way to 
be able to do that and ensure that it is quality and realistic. 

We have heard about vaccinations, and Lord only knows, we 
want the research to go on. I think we could probably make our 
first progress in the diagnosis — I would hope. Vaccine, yes, but 
that's going to take some time. 

Ms. Forschner. Vaccines are in human trial right now. 

The Chairman. Well, we can only hope that the trials are suc- 
cessful. 

The challenges you face in terms of being dropped by your insur- 
ance, bankruptcy of families, is another reason out there for na- 
tional health insurance. We are constantly reminded about it, but 
this just underlines it one more time. 

And the importance of research — I know we can't wave a magic 
wand and resolve all of these issues in terms of research, but it is 
a pretty good indication of our priorities in terms of what we as a 
society are prepared to do in terms of research. One of the really 
sad aspects, even in terms of this budget reconciliation, is the 
freeze that we are putting on in terms of research in domestic 
spending. This is tough stuff that we're talking about in terms of 
belt-tightening out there, and that is something that is difficult, 
but there is no reason that we can't find within our resources the 
kinds of resources that are necessary in this area, and we are cer- 
tainly committed to doing that and will work very closely with all 
of you — and the researchers, NIH, CDC, whom we'll hear from 
later on this morning — to see now that can be effectively done. 

I just want to express enormous appreciation for the testimony. 
We know it is very, very difficult to talk about these personal mat- 
ters. 

I might just take another moment to ask Ms. Keane-Myers, do 
you feel that you are cured now? What is your own assessment? 

Ms. Keane-Myers. I think that since I was treated early on in 
the disease — I did have recurrent conjunctivitis for a long period of 
time, which is one of the symptoms of chronic Lyme disease, and 
was treated later on for another symptom, with a month-long dose 
of tetracycline. So I think that I probably am cured of the disease. 
But that was because I was aware of the symptoms, and I was able 
to get treatment very quickly. 

If I had not been aware of the symptoms, if I didn't know that 
I was in an endemic area, and I didn't go to the physician and say, 
"I think I have Lyme disease," I don't think that I would feel the 
same way. 

The Chairman. I am going to recognize Senator Kassebaum. I 
am the floor manager for the nomination of Dr. Joycelyn Elders for 



49 

Surgeon General, who will be responsible for all public health poli- 
cies. People can ask why public health issues and questions are im- 
portant, and we've got one more example about what sensitive and 
compassionate policy can really be all about. 

My colleagues will continue through the course of the hearing, 
and I will read through all the testimony. I am enormously grateful 
to all of you. 

I have asked Senator Wellstone if he would chair the remainder 
of the hearing, and he has agreed to, and I will now yield to Sen- 
ator Kassebaum. 

Senator Kassebaum. Thank you, Mr. Chairman. 

Just briefly, I was so impressed with the eloquent testimony and 
want to express my appreciation for your coming and the leader- 
ship you are providing in what really is a wake-up call. I must say, 
coming from Kansas, where it isn't something that we think about 
that much, I have read about it — and you can read about it, but 
until you hear someone like each of you and what you have gone 
through, it really doesn't make the impact. I can only say now 
gratetal I am to you, Evan, and to everybody, for taking the time 
to come today and share with us and with the rest of the country 
the problems of Lyme disease. 

As I said, I think it is something that most of us don't under- 
stand or don't realize unless we have been in areas where it has 
been prevalent. So my appreciation and thanks to all of you. 

We will now receive a statement by Senator Durenberger. 

[The prepared statement of Senator Durenberger follows:] 

Prepared Statement of Senator Durenberger 

Mr. Chairman, I am grateful that you have called this hearing 
for today. Lyme disease is an Important health concern to Minneso- 
tans, and therefore important to me. 

In 1992, the Minnesota Department of Health reported 196 cases 
of Lyme disease, a 139 percent increase from 1991. One hundred 
six cases were reported in the Twin Cities and 72 in 10 counties 
north of the Twin Cities — the most endemic counties in Minnesota. 
Of the one hundred six cases, most of the individuals were exposed 
to ticks in the counties just north of the Twin Cities and contiguous 
to Wisconsin. The Metropolitan Mosquito Control District has con- 
firmed that several counties in the metropolitan area are endemic 
for deer ticks — the carriers of the disease. 

And these figures may only tell part of the story. The numbers 
are from reported cases only. There are many Minnesotans who be- 
lieve that the number of people with Lyme disease is higher. 

In response to the incidence and spread of Lyme, In 1991, con- 
cerned Minnesotans formed a nonprofit organization, the Lyme 
Disease Coalition of Minnesota, to help coordinate and elevate pub- 
lic awareness of the disease. Lyme disease support groups also 
have formed to respond to the concerns of the growing number of 
Lyme patients. According to Barb Jones, the Coordinator for Lyme 
Disease Support Groups in Minnesota, there are 18 of these groups 
in the State today. 

So we know that Lyme disease is a problem, and a serious one. 
However, there is a great deal of uncertainty about diagnosis and 
treatment. And that has led to frustration, particularly among 



50 

those who have suffered or who have loved ones who have experi- 
enced its ravages. 

The uncertainty stems from the vagueness of the symptoms 

which can include fatigue, weakness, numbness and stiff joints — 
and the need for more physician and patient education about the 
disease. Also, there is no standardized diagnostic test and there are 
reported disparities in test outcomes from different laboratories. All 
this makes it difficult for physicians to confirm suspicions of Lyme 
disease, and has led to accusations of under and over diagnosis of 

the disease. 

I remember some years back when the daughter of two good 
friends, one of whom works on my staff in Minnesota, contracted 
Lyme disease. As a young girl and teenager Ashley Holderness was 
extremely athletic — a champion swimmer and figure skater in Min- 
nesota. She was one of those people who rarely got sick. She was 
always on the go. Unfortunately, it was partly due to her incredible 
stamina that left Lyme undiagnosed for a year. But it was also due 
to the obvious change in her athletic ability that finally brought at- 
tention to the disease. 

On and off for about a year Ashley seemed to be sick with the 
flu. She also tired easily, experienced agonizing headaches, dizzi- 
ness and shakiness. Ashley forced herself to try and continue her 
normal schedule of school and sports. Her swimming times, how- 
ever, became progressively worse. When it got to the point where 
Ashley didn't think she could swim the length of the pool, her 
mother took her in to see the doctor. 

A battery of tests run by an infectious disease specialist, which 
included tests for Leukemia, Lupus and Lyme, came up positive for 
Lyme. She was immediately prescribed antibiotics. For 3 years 
Ashley endured oral and intravenous antibiotic treatments. She re- 
calls that especially after the IV treatment, there was a definite 
difference in the way she felt — she was getting better. Her mother 
describes it as the periods of sickness getting snorter, and the time 
between those periods growing longer. 

Since going off the treatment, she says she feels fine and can 
carry on a normal life. However, she still gets headaches when 
years ago she never did. And she said she tires more easily than 
friends her age. 

Like many Lyme sufferers especially in the 1980's, Ashley s dis- 
ease was not diagnosed in the initial stages. If It had been diag- 
nosed earlier, 4 years of her life may not have been consumed by 
continuous Illness. Ashley missed out on school and her sports. 
Some Lyme suffers have had to leave their jobs. 

Frustration over lack of information and misdiagnoses have 
helped stoke the fire around the issues associated with prevention, 
diagnosis and treatment. And we'll here about these issues today. 
As a society, we know more about Lyme now than we did In 1982. 
But there is still a ways to go. 

The Minnesotans who have called my office have asked that keep 
an open mind during this hearing. They asked that I listen to the 
information presented and learn a little more about this complex 
disease. And Mr. Chairman, that is exactly what I intend to do. 

Senator Wellstone [presiding]. Senator Metzenbaum. 



51 

Senator Metzenbaum. I just can't tell you how grateful I am to 
each of you for being here today. I think you have sounded a clar- 
ion call that we ought to get off our butts and do something about 
this. Frankly, I think it is an illness that has been swept under the 
carpet, and not many people have paid attention to it, and have 
saia, oh, that's some little tick that doesn't matter. I have heard 
of Lyme disease, but it hasn't struck me with the strength of your 
testimony today. 

And I must confess to you that the argument will be, "Well, 
where are we going to get the money to do the research?" I can tell 
you this. When I see how much money is wasted by this Govern- 
ment and how many giveaways we have for special interest cor- 
porations that have well-paid lobbyists, including those who are 
ripping off the Government in this budget reconciliation bill, I say 
dammit, isn't it incredible what we could do with $100 million, 
$200 million — it's just a drop in the bucket compared to the give- 
aways some corporations have been able to engineer in that bill. 

I will just say to you that I only expect to be here 17 months 
more, but before I leave here, I will work with the chairman and 
the ranking member, and we will somehow get research money 
going, put into this area, to do something about it. 

You are all very strong people. This young man is particularly 
strong to be able to be here with us today and talk about this. And 
we just owe it to you. We owe it to you to see to it that we find 
an answer, that we do the research, and if we can't find the answer 
the first week, the first month, the first year, at least to keep work- 
ing on it. And I promise you that with others on this committee 
and others in the Congress, we are going to at least make the ef- 
fort. We aren't doing enough right now. 

Senator Wellstone. Ms. Forschner, did you want to respond? 

Ms. Forschner. Yes. I think that's a great comment you made, 
and I just wanted to say, too, that I don't think everybody is over- 
whelmingly asking for lots and lots of money to be put into Lyme 
disease. I think we are asking for it to be directed toward the prob- 
lems people on the front lines are having. We are talking about 
chronic illness and a better test. NIH has a better test. It is sitting 
there. We had to fund it because NIH didn't have money to fund 
it. So we sent $5,000 over, and then $30,000, to the Government. 

So we are asking for a better-coordinated program, more front- 
line sensitivity; no lowering the indirect rate on your grant pro- 
grams to 25 percent, as the GAO has suggested, instead of 70 per- 
cent—Government waste. That goes to gold toilet seats in some 
places. So we think that the current budget — let's say we can't get 
any more money — can be run much more efficiently, and we can 
also run it more efficiently by coordinating some of the efforts in- 
side CDC and NIH at the top level, under Joycelyn Elders possibly, 
because the DoD has programs, and the Park Service has programs 
on Lyme disease. 

Instead of a massive duplication of effort, maybe we can stream- 
line what we do, focus the research funds, get a little bit more pub- 
lic-oriented attitude, and take a look at the real problem of chronic 
illness. It is not do you treat more than 28 days — let's prevent you 
from getting medicine — it is what is it that is happening to these 
chronic patients. And I think that is what you hear here, is that 



52 

we need a better focused program; we need a real leader in a posi- 
tion to say, okay, this is what we're going to do, boom, boom, boom, 
and let's go forward. 
Senator Wellstone. Senator Thurmond. 

Opening Statement of Senator Thurmond 

Senator Thurmond. Thank you, Mr. Chairman. 

Mr. Chairman, it is a pleasure to be here this morning to receive 
testimony concerning Lyme disease. I'd like to join you and the 
members of this committee in welcoming our witnesses here today. 

Mr. Chairman, Lyme disease is primarily spread by ticks which 
can be found across the country. Infected ticks can be carried by 
animals such as dogs, cats, deer, horses, and birds. From 1982 to 
1991, over 40,000 cases of Lyme disease were reported; over 50 
cases were reported in my home State of South Carolina between 
1985 and 1991. 

Lyme disease is difficult to diagnose. There appears to be no 
widely-accepted test that can directly detect when the infection is 
present. However, if left untreated, Lyme disease can cause severe 
damage to the heart, brain, eyes, lungs, liver and kidneys. It can 
also affect fetal development. 

Mr. Chairman, if Lyme disease is detected early, oral antibiotics 
are generally effective. This treatment may be continued for 10 to 
30 days depending on the symptoms. However, the recognition and 
treatment of chronic Lyme disease is controversial. Possibly the 
best cure for Lyme disease is prevention and public awareness. 

I also believe this hearing today may help increase the aware- 
ness of this spreading disease and address the controversial issues 
surrounding its recognition and treatment. 

Mr. Chairman, I want to welcome our witnesses again here today 
and look forward to receiving their testimony. I want to congratu- 
late you for holding this hearing. 

Senator Wellstone. Thank you, Senator Thurmond. 

Senator Dodd. 

Senator Dodd. Thank you, Mr. Chairman. I will be brief. 

I think your last point about coordinating the efforts, Karen, is 
a very wise and good suggestion in terms of trying to bring to- 

f ether resources and deal with the front-line issues that have been 
rought up. And I suspect we can get some broad-based support for 
that approach. 

Let me thank all of you for being here today. As so often is the 
case, you put a human face on these issues. The next panel of very 
talented and bright people deal with these issues in numbers and 
statistics. But for people who are unaware of what we are dealing 
with, it only becomes clear to them when they can actually see and 
listen to people who are living with it. 

I always say it takes a certain amount of courage for people to 
step forward and talk about personal problems, but you represent 
literally thousands upon thousands of people who obviously can't 
all be here and can't all testify. So it takes a special sort of courage 
to be willing to come forward and talk about very personal, very 
painful matters, but it is tremendously helpful. 

We thank you. 



53 

Senator Wellstone. And I also would like to thank the panel- 
ists. I cannot say it better than Senator Dodd just said it. 

Just an apology. There was another committee hearing that I 
had requested at the same time, so my apology for coming in later 
due to that conflict. 

Thank you all very much. We will now move on to the second 

panel. 

Our second panel is composed of health professionals engaged in 
the control and treatment of Lyme disease. Dr. Piatt and Dr. 
Cartter will tell us about the spread of Lyme disease. Dr. Piatt is 
a veterinary microbiologist on the faculty of Iowa State University. 
Dr. Cartter is the epidemiology program coordinator for the State 
of Connecticut. 

Dr. Allen Steere is director of the Lyme Disease Program at the 
New England Medical Center of Tufts University, and Dr. Joseph 
J. Burrascano, Jr., is a private practitioner from East Hampton, 
NY. , 

We thank all of you for being here, and we will start with the 
introduction from the Honorable George Hochbrueckner. 

Senator Dodd. Mr. Chairman, I'd just like to welcome Dr. 
Cartter. As you pointed out, Dr. Cartter is an epidemiologist from 
Connecticut. He graduated from Cheshire High School and Wes- 
leyan University as well, and I gather is highly respected and tre- 
mendously appreciated for his efforts. We are pleased you are here. 

Dr. Cartter. Thank you, Senator Dodd. 

Senator Wellstone. Congressman, we are glad you are here. 

STATEMENT OF HON. GEORGE HOCHBRUECKNER, A U.S. 
REPRESENTATIVE FROM THE STATE OF NEW YORK 

Mr. Hochbrueckner. Mr. Chairman, members of the committee, 
I am delighted that you are having this hearing today on Lyme dis- 
ease, as this is the first congressional hearing ever held on this 
subject. I commend you for your recognition of now serious and de- 
bilitating this disease can be and your concern for patients who are 
suffering from it and turning to their Government for help. 

You are also to be commended for your interest in the progress 
of Federal research on Lyme disease currently under way and vour 
consideration of whether additional funds are needed in light of the 
seriousness of the disease and its rapid spread across our Nation. 

I am pleased to advise the committee that I have introduced leg- 
islation to provide new research funding to fight Lyme disease, in- 
cluding the creation of five national Lyme disease centers under 
the direction of the Centers for Disease Control. 

I am providing the committee with a copv of my bill, H. R. 2813, 
the Lyme Disease Prevention, Control, and Research Amendments 
of 1993, which I hope you will give serious consideration. 

I also request that my separate formal statement be inserted in 
the record. 

As the Member of Congress who has the unfortunate distinction 
of having the most reported cases of Lyme disease from his district 
and who has introduced many pieces of legislation to promote 
awareness and provide research funding to combat Lyme disease, 
I am delighted that you have given me the opportunity to address 
you today and to introduce my constituent, Dr. Joseph Burrascano, 



54 

of East Hampton, NY, who will provide the committee with his 
views on the medical treatment of Lyme patients. 

But let me say a few words off-the-cuff, if I may. When I first 
started to promote Lyme disease as a problem in the Congress 7 
years ago, when I first started talking to my colleagues in the 
House, many of the members thought that Lyme disease was a cit- 
rus disease affecting lemons and oranges and grapefruit. But we 
have come a long way since then, and rightly so. 

Much work has been done, as you have heard and will hear, on 
a more effective test, since Lyme disease does mimic other diseases, 
certainly on a vaccine, which is now going into trial; on education 
both for the medical community ana individuals — and certainly 
Karen Forschner has had a lot to do with that — and certainly, the 
control of deer and mice, which are the main hosts for the Lyme 
disease tick. 

Even on the House Armed Services Committee, which I have now 
served on for 7 years, with the military, an appreciable amount of 
work has been done by the military that is applicable to the civil- 
ian population. Clearly, what they have found after millions of dol- 
lars of research is that there is a good personal protection for peo- 
ple, that by use of promethin-based spray for the clothing coupled 
with a deep-based lotion for the skin — it even comes today with a 
sunblock — you can provide close to 97 percent protection for indi- 
viduals until we do in fact come up with the ability to stop this dis- 
ease. 

So there are many, many things going on out there, and there 
is much work going on, but it is important that we keep the pres- 
sure on and continue doing what we must do. So we have come a 
long way; clearly, we still have a long way to go. 

At this point, I am delighted to present my constituent, Dr. Jo- 
seph Burrascano of East Hampton for his testimony. 

Senator Wellstone. Dr. Burrascano. 

STATEMENTS OF DR. JOSEPH BURRASCANO, JR., PHYSICIAN, 
EAST HAMPTON, NY; KENNETH B. PLATT, VETERINARY 
MICROBIOLOGIST, IOWA STATE UNIVERSITY, AMES, IA; DR. 
MATTHEW CARTTER, EPIDEMIOLOGY PROGRAM COORDINA- 
TOR, STATE OF CONNECTICUT, HARTFORD, CT, AND DR. 
ALLEN C. STEERE, PROFESSOR OF MEDICINE, NEW ENG- 
LAND MEDICAL CENTER, TUFTS UMVERSITY SCHOOL OF 
MEDICINE, BOSTON, MA 

Dr. Burrascano. Thank you very much for holding this commit- 
tee meeting, and again, thank you for the very nice introduction. 

You have heard today that there are many problems in the field 
of Lyme disease, and I want to address one of the core problems 
that you may not be aware of. Some have called this the "Lyme dis- 
ease conspiracy." 

There is in this country a core group of university-based Lyme 
disease researchers and physicians whose opinions carry a great 
deal of weight. Unfortunately, many of them act unscientifically 
and unethically. They adhere to outdated, self-serving views and at- 
tempt to personally aiscredit those whose opinions differ from their 
own. They exert strong, ethically questionable influence on medical 
journals, which enables them to publish and promote articles that 



55 

are badly flawed. They work with Government agencies to bias the 
agenda of consensus meetings and have worked to exclude from 
these meetings and scientific seminars those with ultimate opin- 
ions. 

They behave this way for reasons of personal or professional gain 
and are involved in obvious conflicts of interest. This group pro- 
motes the ids* that Lyme is a simple, rare illness that is easy to 
avoid, difficult to acquire, simple to diagnose, and easily treated 
and cured with 30 days or less of antibiotics. 

The truth, however, is that Lyme is the fastest-growing infec- 
tious illness in this country after AIDS, with the cost to society 
measured in the billions of dollars. It can be acquired by anyone 
who goes outdoors, and very often goes undiagnosed for months, 
years, or even forever in some patients, and can render the patient 
chronically ill and even totally disabled despite what this core 
group of physicians refers to as "adequate'' therapy. 

They feel that when the patient fails to respond to their treat- 
ment regimen, which is a common occurrence, it is not because the 
treatment has failed, but because they have developed a new ill- 
ness, what they call the "post Lyme syndrome." They claim that 
this is not an infectious problem, but a rheumatologic or arthritic 
malady due to activation of the immune system. 

The fact is, this cannot be related to any consistent abnormality, 
but it can be related to a persistent infection. As further proof, vac- 
cinated animals now in the vaccine trials whose immune system 
has been activated by Lyme disease have never developed this post 
Lyme syndrome. Yet on the other hand, there is a great deal of sci- 
entific proof that persistent infection can exist in these patients be- 
cause the one-month treatment did not eradicate the infection. 

Indeed, many chronically ill patients whom these physicians 
have dismissed have gone on to respond to, positively, and even re- 
cover, when additional antibiotics are given. 

It is also interesting to me that these individuals who promote 
this so-called "post Lyme syndrome" as a form of arthritis depend 
on funding from arthritis groups and agencies to earn their liveli- 
hood. Some of them are known to have received large consulting 
fees from insurance companies to advise the companies to curtail 
coverage for any additional therapy beyond the arbitrary 30-day 
course. And this is even though the insurance companies ao not do 
this for other illnesses. 

Following the lead of this group of physicians, a few State health 
departments have now begun to investigate, in a very threatening 
way, physicians who have more liberal views on Lyme disease diag- 
nosis and treatment than they do. And indeed, I have to confess 
that today I feel that I am taking a personal risk, a large one, be- 
cause I am stating these views publicly, for fear that I may suffer 
some repercussions despite the fact that many hundreds of physi- 
cians and many thousands of patients all over the world agree with 
what I am saying here today. 

Because of this bias by this inner circle, Lyme disease unfortu- 
nately is both underdiagnosed and undertreated in this country to 
the great detriment of many of our citizens. Let me address these 
individually. 



56 

With underdiagnosis, the first problem is underreporting. The 
current reporting criteria for Lyme disease are inadequate and 
miss an estimated 30 to 50 percent of patients. Some States cur- 
tailed their active surveillance programs and saw an artificial drop 
in reported cases of nearly 40 percent, leading the uninformed to 
believe incorrectly that the number of new cases of Lyme is on the 
decline. 

The reporting procedure is often so cumbersome that many phy- 
sicians have never bothered to report cases at all, and some physi- 
cians who have reported a large number of cases have found them- 
selves targets of State health department investigations. Finally, 
too many physicians and Government agents rely on the notori- 
ously unreliable serologic blood test to confirm the diagnosis. 

That brings me to my second point, which is the poor diagnostic 
testing. It is very well-known that the serologic blood test for Lyme 
is insensitive, inaccurate, not standardized, and misses up to 40 
percent of cases; yet many physicians, including many of those re- 
ferred to above, and the senior staff at CDC and NIH, insist that 
if the blood test is negative, then the patient could not possibly 
have Lyme. This view is not supported by the facts. Lyme is diag- 
nosed clinically and can exist even when the blood test is negative. 

The Rocky Mountain Lab of the NIH, which is the country s best 
laboratory for Lyme research, had developed an excellent diag- 
nostic test for this illness nearly 4 years ago, but further work on 
it has been stalled. Incredibly, if not for private donations to the 
Government from the National Lyme Disease Foundation, this and 
other related research would have had to be abandoned. Yet many 
physicians believe that thousands of dollars of grant moneys al- 
ready awarded by the Government to other outside researchers is 
poorly directed, supporting work of low relevance and low priority 
to those sick with Lyme. In spite of this, their funding continues, 
and the Rocky Mountain Lab is still underfunded. 

The third point is that the university and Government-based es- 
tablishment deny the existence of atypical presentations of Lyme, 
as some of those you have heard today, and the patients in this cat- 
egory are not being diagnosed or treated and have no place to go 
for proper care. 

The result of all this is that some Lyme patients have had to see. 
in my experience, as many as 42 different physicians over several 
years before being properly diagnosed, and also at tremendous cost 
to themselves. 

Unfortunately, the disease was left to progress during that time, 
and these patients were left forever ill, for by that time the illness 
was not able to be cured. 

Under the second category of undertreatment, number one is be- 
cause the diagnosis is not being made properly in many patients. 
Second, university-based and Government-endorsed treatment pro- 
tocols are empiric, insufficient, refer to studies involving inad- 
equate animal models, and are ignorant of basic pharmacology. 
They are not based on honest, systematic studies or on the results 
of newer information. 

Third, after short courses of treatment, patients with advanced 
disease rarely return to normal, yet many can be proven to still be 
infected and can often respond to further antibiotic therapy. Unfor- 



57 

tunately, Lyme patients are being denied such therapy for political 
reasons and/or because insurance companies refuse to pay for these 
longer treatments. 

Fourth, long-term studies on patients who are undertreated or 
untreated demonstrated the occurrence of severe illness more than 
a decade later, reminiscent of the findings of the notorious 
Tuskegee Study. We have to take this illness seriously. 

Senator Wellstone. Dr. Burrascano, I don't want to be rude, but 
we're going to ask all of you to try to keep within about a 5-minute 
time frame. 

Dr. Burrascano. I am on the last paragraph. 

Senator Wellstone. OK I apologize. We just want to make sure 
that everybody has a chance to testify. 

Dr. Burrascano. I understand. 

Finally, the Lyme disease bacterium spreads to areas of the body 
that render this organism resistant to being killed by the immune 
system and by antibiotics, such as in the eye, deep within tendons, 
and within cells. The Lyme bacterium also has a very complex life 
cycle that renders is resistance to simple treatment strategies. 
Therefore, to be effective, antibiotics must be given in generous 
doses over a long period of time, sometimes many months, until 
signs of active infection have cleared. Also, because relapses have 
appeared very late, decades of follow-up are required before you 
can say someone has been adequately treated. 

I have to close by saying the very existence of hundreds of Lyme 
support groups in this country, and the tens of thousands of dissat- 
isfied, mistreated, and ill patients whom these groups represent, 
underscores the many problems that exist out in the real world of 
Lyme disease. I ask and plead with the committee to hear their 
voices, listen to their stories, and work in an honest and unbiased 
way to help and protect the many Americans whose health is at 
risk from what has now become a political disease. 

Thank you. 

[The prepared statement of Dr. Burrascano follows:] 

Prepared Statement of J. J. Burrascano, Jr., M.D. 

CURRENT PROBLEMS IN THE LYME DISEASE FIELD 

I began treating Lyme patients in the mid 1980's in an area said to the highest 
case rate of Lyme Disease in the world. I have personally seen and managed the 
care of several thousand patients with this illness, and patients have come to me 
from thirty eight states and eight countries. Physicians from all around the world 
call me daily lor my advice, and my copyrighted guidelines for diagnosis and treat- 
ment, currently in its eighth edition 1 has been distributed world wide, and has been 
translated into three languages. I have attended every major conference on this sub- 
ject, and have presented original research papers at many of them. I do not receive 
any unreasonable personal gain for the treatments I prescribe. I do not now, and 
never have accepted money from pharmaceutical or home care companies in ex- 
change for my referrals, and I manage patients as I do because I believe it is the 
correct approach. I came here today at my own expense because I take seriously this 
illness and the implications of thin meeting here. 

THE LYME DISEASE CONSPIRACY 

There is a core group of university based Lyme Disease researchers and physi- 
cians whose opinions carry a great deal of weight. Unfortunately, many of them act 
unscientifically and unethically. They adhere to outdated, self serving views and at- 
tempt to personally discredit those whose opinions differ from their own. They exert 
strong, ethically questionable influence on medical Journals, which enables them to 



58 

publish and promote articles that are badly flawed. They work with government 
agencies to bias the agenda of consensus meetings, and have worked to exclude from 
these meetings and from scientific seminars those with alternate opinions. They be- 
have this way for reasons of personal or professional gain, and are involved m obvi- 
ous conflicts of interest. . 

This group promotes the idea that Lyme is a simple, rare illness that is easy to 
avoid, difficult to acquire, simple to diagnose, and easily treated and cured with 
thirty days or less of antibiotics. .•■... 

The truth is that Lyme is the fastest growing infectious illness m this country 
after AIDS, with a cost to society measured in the millions of dollars. It can be ac- 
quired by anyone who goes outdoors, very often goes undiagnosed for months, ears, 
or forever in some patients, and can render a patient chronically ill and even totally 
disabled despite what this core group refers to as "adequate" therapy. There have 
been deaths from Lyme Disease. 

They feel that when the patient fails to respond to their treatment regimens, it 
is because the patient developed what they named "the post 

Lyme syndrome". They claim that this is not an infectious problem, but a 
rheumatologic or arthritic malady, due to activation of the immune system. 

The fact is, this cannot be related to any consistent abnormality other than per- 
sistent infection. As further proof, vaccinated animals whose immune system has 
been activated by Lyme, have never developed this syndrome. On the other hand, 
there is proof that persistent infection can exist in these patients because the 1 
month treatments did not eradicate the infection. Indeed, many chronically ill pa- 
tients, whom these physicians dismissed, have gone on to respond positively and 
even recover when additional antibiotics are given. 

It is interesting that these individuals who promote this so called post Lyme 
syndrome"as a form of arthritis, depend on funding from arthritis groups and agen- 
cies to earn their livelihood. Some of them are known to have received large consult- 
ing fees from insurance companies to advise them to curtail coverage for any anti- 
biotic therapy beyond this arbitrary thirty day cutoff, even if the patient will suffer. 
This is despite the fact that additional therapy may be beneficial, and despite the 
fact that such practices never occur in treating other diseases. 

Following the lead of this group of physicians, a few State health departments 
have evenbegun to investigate, in a very threatening way, physicians who have 
more liberal views on Lyme Disease diagnosis and treatment than they do. Indeed, 
I must confess that I feel that I am taking a large personal risk here today by pub- 
licly stating these views, for fear that I may suffer some negative repercussions, de- 
spite the fact that many hundreds of physicians and many thousands of patients 
all over the world agree with what I am saying here. ^^ 

Because of this bias by this inner circle, Lyme disease is both underdiagno5e@@ 
and undertreated, to the great detriment to many of our citizens. Let me address 
these points in more detail. 

UNDERDIAGNOSE 

1. Under reporting: The current reporting criteria for Lyme are inadequate and 
miss an estimated 30% to 50% of patients Some states curtailed their active surveil- 
lance programs and saw an artificial drop in reported cases of nearly 40%, leading 
the uninformed to believe incorrectly that the number of new cases of Lyme is on 
the decline. The reporting procedure is often so cumbersome, many physicians never 
bother to report cases. Some physicians who have reported a large number of cases 
have found themselves the target of State health department investigators. Finally, 
too many physicians and government agents rely on the notoriously unreliable sero- 
logic blood test to confirm the diagnosis. 

2. Poor Lyme Disease diagnostic testing: It is very well known that the serologic 
(blood) test for Lyme is insensitive, inaccurate, not standardized, and misses up to 
40% of cases, yet many physicians, including many of those referred to above, and 
the senior staff at CDC and NIH, insist that if the blood test is negative, then the 
patient could not possibly have Lyme. This view is not supported by the facts. Lyme 
is diagnosed clinically, and can exist even when the blood test is negative. 

The Rocky Mountain Lab of the NIH, which is the country's best government lab- 
oratory for Lyme research, had developed an excellent diagnostic test for this illness 
nearly 4 years ago, yet further work on it has been stalled. Incredibly, if not for 
private donations of just $5,000 from the nonprofit National Lvme Disease Founda- 
tion headquartered in Connecticut, then this research would have had to be aban- 
doned. An additional $30,000 was donated by this organization to allow them to con- 
tinue other valuable projects relating to vaccine development and disease patho- 
genesis. Yet, many physicians believe that thousands oT dollars of grant moneys 



59 

awarded by the government to other, outside researchers is poorly directed, support- 
ing work of low relevance and low priority to those sick with Lyme. In spite of this, 
their funding continues, and the Rocky Mountain Lab is still underfunded. 

3. The university and government based Lyme establishment deny the existence 
of atypical presentations of Lyme, and patients in this category are not being diag- 
nosed or treated, and ave no place to go to for proper care. 

Results: Some Lyme patients have had to see as many as forty two different doc- 
tors, often over several years, and at tremendous cost, before being properly diag- 
nosed. Unfortunately, the disease was left to progress during that time, and patients 
were left forever ill, for by that time, their illness was not able to be cured. Even 
more disturbing, these hard line physicians have tried to dismiss these patients as 
having '.Lyme Hysteria" and tried to claim they all were suffering from psychiatric 
problems! 

UNDEKTREATMENT 

1. Because the diagnosis is not being made, for reasons partly outlined above. 

2. University based and government endorsed treatment protocols are empiric, in- 
sufficient, refer to studies involving inadequate animal models, and are ignorant of 
basic pharmacology. They are not based on honest systematic studies or on the re- 
sults of newer information. 

3. After short courses of treatment, patients with advanced disease rarely return 
to normal, yet many can be proven to still be infected and can often respond to fur- 
ther antibiotic therapy. Unfortunately, Lyme patients are being denied such therapy 
for political reasons and/or because insurance companies refuse upon the arbitrary 
and uninformed advice of these physicians, who are on the insurance company's 
payroll. 

4. Long-term studies on patients who were untreated or undertreated dem- 
onstrated the occurrence of severe illness more than a decade later, reminiscent of 
the findings of the notorious Tuskeege Study, in which intentionally untreated 
syphilis patients were allowed to suffer permanent and in some cases fatal sequelae. 

5. The Lyme bacterium spreads to areas of the body that render this organism 
resistant to being killed by the immune system and by antibiotics, such as in the 
eye, deep within tendons, and within cells. The Lyme bacterium also has a very 
complex lifecycle that renders it resistant to simple treatment strategies. Therefore, 
to be effective, antibiotics must be given in generous doses over several months, 
until signs of active infection have cleared. Because relapses have appeared long 
after seemingly adequate therapy, long-term followup, measured in years or dec- 
ades, is required before any treatment regimen is deemed adequate or curative. 

6. When administered by skilled clinicians, the safety of long-term antibiotic ther- 
apy has been firmly established. 

The very existence of hundreds of Lyme support groups in this country, and the 
tens of thousands of dissatisfied, mistreated, and ill patients whom these groups 
represent, underscores the many problems that exist out in the real world oi Lyme 
Disease. I ask and lead with you to hear their voices, listen to their stories, and 
work in an honest and unbiased way to help and protect the Americans whose 
health has is at risk from what has now become a political disease. 

Thank You. 

Senator Wellstone. Thank you very much, Dr. Burrascano, and 
I do apologize again for the interruption. Your testimony is very 
important. 

Dr. Piatt. 

Mr. Platt. I am a veterinary microbiologist at the College of Vet- 
erinary Medicine, Iowa State University, and I have been actively 
involved in Lyme disease research since 1986. 

I first became involved with Lyme disease when I organized a 
Lyme disease surveillance program at Fort McCoy in south central 
Wisconsin with U.S. Army Reserve veterinary components associ- 
ated with the 330th Medical Brigade at Fort Sheridan, IL. Our pri- 
mary task was to identify and characterize areas of high deer tick 
density and to assess the threat of Lyme disease exposure to mili- 
tary and civilian personnel. 

Subsequently, a public awareness campaign was initiated, which 
we felt dramatically reduced the risk of exposure to Lyme disease. 



60 

In addition, tick abatement measures were initiated in specific 
areas of high public use, which also appeared to markedly reduce 
the risk and the tick population. 

Similar surveillance studies were initiated by myself and my 
medical entomological personnel in Iowa, where the incidence of 
Lyme disease is slowly increasing. As a result of these efforts, we 
have been able to monitor the southern and western movement of 
the deer tick across the eastern third of Iowa. At the present time, 
the largest populations of ticks infected with the Lyme disease or- 
ganism exist in the northeast corner of the State. Although infected 
ticks have been found occasionally in other parts of eastern Iowa, 
it is not clear whether or not areas of endemnicity will develop, and 
we are continuing to monitor this situation. 

We are also concerned about the presence of large populations of 
the lone star tick in southern Iowa. Although this tick is not con- 
sidered to be a highly effective vector for a variety of reasons, its 
relatively large population is a cause for some concern, especially 
since it is possible that the southern movement of the deer tick 
along the Mississippi River may result in the permanent establish- 
ment of the Lyme disease organism in this region. Our current sur- 
veillance of the region indicates that this may have already oc- 
curred. 

It is our opinion that the best way to control Lyme disease is to 
keep the public fully informed of the relative risk of exposure in 
specific geographical areas. Accordingly, we are conducting con- 
trolled field and laboratory studies which we believe will lead to 
the eventually development of a model that will make it possible 
to realistically assess and predict the threat of Lyme disease to the 
public in the Upper Midwest. 

For example, because the threat of exposure to the Lyme disease 
organism is directly related to the tick population, we studied and 
defined the life cycle of the tick in the Upper Midwest and com- 
pared it to the life cycle described in the Northeast. Our studies 
found that the life cycles of the ticks in these two regions were es- 
sentially the same, but in the Midwest there appeared to be an ear- 
lier and broader activity period of larval and nymph stages of the 
tick. We don't know at this point how this difference may affect the 
risk of exposure, but it needs further study. 

We have also been actively involved in identifying and character- 
izing other factors that affect the survivability of different stages 
of the tick population and the efficiency by which tick populations 
transmit the organization. 

For example, in the Fort McCoy area, we found that the tick pop- 
ulation not only varies by year, but the infection rates of specific 
tick populations within the area in any given year also vary. 

We have also found that the mean number of Lyme disease orga- 
nisms per tick decreases from the fall to the spring. At the present 
time, we don't know if this lower number of organisms seen in the 
spring population is due to a lower survival rate of overwintering 
ticks infected with the organism or the effect of temperature on the 
survivability of the organism within the tick itself. If the latter is 
the case, it may follow that the ability of ticks to transmit the dis- 
ease following severe winters may be less than that following a 
mild winter. Our studies will clarify this question. 



61 

We are also investigating the effect that the immune status of 
animal reservoirs may have on the establishment and maintenance 
of the Lyme disease organism in tick populations. These studies as 
well as similar studies in other laboratories will help us to better 
understand the complex interrelationship between the Lyme dis- 
ease organism, its vector and its reservoir hosts. It is this knowl- 
edge that will enable us to more precisely and accurately assess 
and predict risk of Lyme disease to a concerned public without cre- 
ating undue alarm. 

If the problem of Lyme disease is to be satisfactorily resolved, it 
will require the continuation of the broadly-balanced scientific ap- 
proach that Federal funding has made possible. This approach has 
included support for surveillance and risk assessment of affected 
geographical areas, vaccine development, and the improvement of 
diagnostic tests. The continued improvement of diagnostic tests is 
of particular importance because in order to assess the true impor- 
tance of a disease in a population, it must be possible to diagnose 
it correctly. This is particularly important with respect to the 
chronic manifestations of Lyme disease. 

Thank you, Mr. Chairman, for the opportunity to present our 
views. 

[The prepared statement of Mr. Piatt follows:] 

Prepared Statement of Kenneth B. Platt, PhD, DVM 

My name is Kenneth B. Platt. I am a veterinary microbiologist at the College of 
Veterinary Medicine, Iowa State University. I have been actively involved in Lyme 
disease research since 1986. 

I first became involved with Lyme disease when I organized a Lyme disease sur- 
veillance program at Fort Mc Coy in south central Wisconsin with US Army Reserve 
Veterinary components of the 330th Medical Brigade located at Fort Sheridan IL. 
Our primary task was to identify and characterize areas of high deer tick (Ixodes 
scapularis) density and to assess the threat of Lyme disease exposure to military 
ana civilian personnel. Subsequently a public awareness campaign was initiated 
which we felt dramatically reduced the risk of exposure to Lyme disease. In addition 
tick abatement measures were initiated in specific areas of high public use which 
appeared to markedly reduce the tick population. 

Similar surveillance studies were initiated by veterinary and medical entomo- 
logical personnel in Iowa where the incidence of Lyme disease is slowly increasing. 
As a result of these efforts we have been able to monitor the southern and western 
movement of the deer tick across the eastern third of Iowa At the present time the 
largest populations of ticks infected with the Lyme disease organism, Borrelia 
burgdorferi exist in the northeast corner of the State. Although infected ticks have 
been found occasionally in other parts of eastern Iowa, It is not clear whether or 
not areas of endemnicity will develop. We are continuing to monitor this situation. 

Wd are also concerned about the presence of large populations of the lone star 
tick (Amblyomma americanum) in southern Iowa. Although this tick is not consid- 
ered to be a highly effective vector for a variety of reasons, its relatively large popu- 
lation is cause for some concern especially' since it is possible that the southern 
movement of the deer tick along the Mississippi river may result in the permanent 
establishment of the Lyme disease organism in this region. Our current surveillance 
of this region indicates that this may nave already occurred. 

It is our opinion that the best way to control Lyme disease is to keep the public 
fully informed of the relative risk of exposure in specific geographical areas. Accord- 
ingly, we are conducting controlled field and laboratory studies which we believe 
will lead to the eventual development of a model that will make It possible to real- 
istically assess and predict the threat of Lyme disease to the public in the upper 
midwest. For example, because the threat of exposure to the Lyme disease organism 
is directly related to the tick population, we studied and defined the life cycle of the 
tick in the upper midwest and compared it to the life cycle described in the north- 
east. Our studies found that the life cycles of the ticks were essentially the same 
in both regions with the exception that in the midwest, larval and nymphal activi- 
ties appear to occur earlier than in the northeast. We do not know at this point how 



73-299 - 93 - 3 



62 

this difference may affect tHe risk of exposure. This is a question that needs further 
study. , . 

we have also been actively involved in identifying and characterizing factors that 
affect the survivability of the different stages of the tick population and the effi- 
ciency by which specific tick populations transmit the Lyme disease organism. For 
example, in the Fort McCoy area, we found that the tick population not only varies 
by year but the infection rates of specific tick populations within the area in any 
given year also vary. We have also found that the mean number of Lyme disease 
organisms per tick decreases from the fall to the spring. At the present time we do 
not know if the lower number of Lyme disease organisms seen in spring populations 
of adult ticks is due to a lower survival rate of overwintering ticks infected with 
the Lyme disease organism or the effect of temperature on the survivability of the 
Lyme disease organism within the tick itself. Ifthe latter is the case it may follow 
that the ability of ticks to transmit Lyme disease following severe winters may be 
less than that following a relatively mild winter. Our studies will clarify this ques- 
tion. 

We are also investigating the affect that the immune status of animal reservoirs 
may have on the establishment and maintenance of the Lyme disease organism in 
tick populations. These studies as well as similar studies m other laboratories will 
help us to better understand the complex interrelationship between the Lyme dis- 
ease organism, its vector and its reservoir hosts, it is this knowledge that will en- 
able us to more precisely and accurately assess and predict risk of Lyme disease 
to a concerned pulic without creating undue alarm. 

If the problem of Lyme disease is to be satisfactorily resolved it will require the 
continuation of the broadly balanced scientific approach that Federal funding has 
made possible. This approach has included support for, surveillance and risk assess- 
ment of affected geographical areas, vaccine development, and improvement of diag- 
nostic tests. The continued improvement of diagnostic tests is of particular impor- 
tance because in order to assess the true importance of a disease in a population 
it must be possible to diagnose it correctly. This is particularly important with re- 
spect to the chronic manifestations of Lyme disease. 

Thank you Mr. Chairman for the opportunity to present our view of the Lyme dis- 
ease problem. I will be happy to answer any questions that you or the committee 
members may have. 

Senator Dodd [presiding]. Thank you very much. You look up 
and you see a new face chairing this hearing every few minutes, 
but Senator Wellstone has another meeting ne has to attend at 
11:30, so 111 be chairing. 

I am pleased to be able to present you once again, Dr. Cartter. 
I'm going to use the lights now. That way you'll have some sense 
of when to start wrapping up — about 6 minutes after you begin, so 
we can get through our last two panelists and then get to some 
questions. 

And by the way, every piece of written testimony, supporting 
data, and information you'd like us to have, I will make a part of 
the record. 

Dr. Cartter. 

Dr. Cartter. I'd like to thank Senator Kennedy and his staff and 
Senator Dodd and his staff for their support of my coming to this 
meeting. 

My name is Matthew Cartter, and I am a physician and an epi- 
demiologist with the Connecticut Department of Public Health and 
Addiction Services. I have been in charge of our Lyme disease ac- 
tivities since 1987. 

It is the job of public health to prevent new cases of Lyme dis- 
ease. It is the job of clinical medicine to make sure that when peo- 
ple get Lyme disease, they are appropriately treated and do not go 
on to develop late complications from the disease. 

In terms of prevention, I am going to be saying some radical 
things here today. We are not doing well enough. We need a na- 
tional strategic plan for the control and prevention of Lyme dis- 



63 

ease, and we need additional Federal resources to back the plan 
up. In public health, our task is to protect the health of our popu- 
lation. We use surveillance and epidemiologic studies to define the 
public health importance of a disease. We then use this information 
to develop, implement and evaluate population-based control and 
prevention strategies. 

In Connecticut, we have one of the most comprehensive Lyme 
disease surveillance systems in the country. We have the highest 
reported rate of Lyme disease of any State. More than 80 percent 
of our cases involve people who have erythema migrans, the char- 
acteristic skin rash of early Lyme disease. Children have the high- 
est rate of this disease and are at special risk. 

From our surveillance, we know that you can get Lyme disease 
in any part of Connecticut, although some parts of Connecticut 
have a much higher risk than others. 

There are two major barriers to improved surveillance for Lyme 
disease. The first is physician underreporting, which has been men- 
tioned. I'd like to point out this is not just a problem with Lyme 
disease, but many physicians do not report cases of any reportable 
disease including Lyme disease. 

The second barrier is resources. As you well know, data cost 
money. In 1991, 16 years after Lyme disease was first studied in 
Connecticut, we were able to hire an epidemiologist dedicated to 
Lyme disease surveillance for the first time. This was done with 
Federal funding. Our enhanced surveillance activities were largely 
responsible for a 48 percent increase in the number of reported 
Lyme disease cases between 1991 and 1992. 

I'd like to turn now to prevention. We have tried to assess the 
effectiveness of our Lyme disease prevention efforts in Connecticut. 
Unfortunately, we have found that our efforts are not doing well 
enough. In a telephone survey of adults in Connecticut done last 
year, we found that 66 percent of the respondents reported they 
know "a lot" or "some" about Lyme disease. Unfortunately, only 
half of these people reported that they had taken any precautions 
to prevent Lyme disease during the past year. 

Recently, with the help of Federal resources, we have been able 
to develop Lyme disease educational videos for primary and second- 
ary school students. Our evaluation of these materials has not yet 
been completed, but what I can tell you is that 6 months after the 
video was shown to 9th grade students, much of the knowledge 
gained by these students about Lyme disease was lost. Behavioral 
changes to prevent Lyme disease are difficult to sustain with short 
educational interventions. 

When people ask what they can do to protect themselves from 
getting Lyme disease, we tell them to wear long pants, use a tick 
repellent, and check themselves for ticks. Last summer, we con- 
ducted a study in the Lyme, CT area to determine whether these 
commonly recommended personal protective measures were effec- 
tive in preventing Lyme disease. We did not find any evidence to 
support their effectiveness. 

In my opinion, the use of these personal protective measures is 
unlikely to lead to a decrease in the incidence of Lyme disease in 
the areas where Lyme disease is common, like in Connecticut. This 



64 

does not mean that we should stop urging people to take these pre- 
cautions. 

Senator Dodd. Does that include, Dr. Cartter, the tick repellent 
or lotion that you talked about? 

Dr. Cartter. That's correct. There is one thing about studying 
it in a scientific setting. It is something else when you actually look 
to see whether or not people can practice these precautions well 
enough in the field. And in looking at Connecticut, in the Old Lyme 
and Lyme, CT area, we found no evidence for effectiveness of any 
of these measures in terms of protection from Lyme disease. 

Senator Dodd. And you found something different? 

Mr. Hochbrueckner. Yes, Senator. The Army's work in the area 
using the promethin-based spray and the deep-based lotion showed 
great effectiveness. Now, perhaps the education of the individuals 
in terms of using the spray for the clothing and the lotion for the 
skin has not gone very well. 

Senator Dodd. We can get back to this in a minute. 

Dr. Cartter. Well, it's one thing to ask military personnel to do 
something, and it's another thing to ask your 9-year-old to wear 
long pants and tick repellent on a 95-degree day in July. 

What we do need, however, is to aggressively pursue the develop- 
ment of more effective preventive measures. The best way to move 
forward on this issue is to develop a national strategic plan for the 
control and prevention of Lyme disease. This plan should define 
the path that will lead us in a timely way to effective primary pre- 
vention measures. These measures should include tick control 
measures that work and an effective Lyme disease vaccine for hu- 
mans. 

Enhanced surveillance for Lyme disease is needed so that the ef- 
fectiveness of future control measures can be assessed. This strate- 
gic plan should, identify the Federal resources that are needed to 
get the job done. 

We will need continued Federal leadership. I would like to com- 
mend the Centers for Disease Control and Prevention for taking a 
leadership role in the public health response to this disease. CDC's 
leadership in this area has been especially apparent since respon- 
sibility for this disease was transferred to the Division of Vector- 
Borne Infectious Diseases in Fort Collins, CO in the fall of 1989. 

I am fully aware that there are other important Lyme disease is- 
sues. Many of these issues, like the diagnosis and treatment of 
chronic Lyme disease, can best be resolved by well-designed clinical 
studies, which are needed and should be funded. These issues need 
to be resolved by the clinical medicine community. The public 
health focus should and must be on preventing new cases of Lyme 
disease. 

The public health approach and the clinical medicine approach 
are both needed to deal with this problem. 

I'd like to thank you for the opportunity to talk about this prob- 
lem with you. We in Connecticut are grateful for the Federal sup- 
port of our Lyme disease activities. 

I would be happy to entertain any questions. 

[The prepared statement of Dr. Cartter follows:! 



65 

Prepared Statement op Matthew L. Cartter, M.D. 

I am Matthew L. Cartter, M.D., Epidemiology Program Coordinator for the Con- 
necticut Department of Public Health and Addiction Services. I have been in charge 
of the Department's response to Lyme disease since 1987. 

In public health approach, our patient is our population. We use surveillance and 
epidemiologic studies to define the public health importance of a disease. We then 
use this information to develop, implement, and evaluate population-based control 
and prevention strategies. 

In Connecticut, we have one of the most comprehensive Lyme disease surveillance 
systems in the country. We have the highest reported rate of Lyme disease (54 cases 
per 100,000 population in 1992) of any State. More than 80% of our cases involve 
persons who have erythema migrans, the characteristic skin rash of early Lyme dis- 
ease. From Surveillance, we know that Lyme disease can be acquired in any county 
in Connecticut, that some areas of the State remain much more affected than oth- 
ers, and that the disease has spread inland and westward along the coast since 
1977. This information has been used to guide our education efforts and to identify 
research and education needs for Federal funding. 

There are two major barriers to improved surveillance for Lyme disease. The first 
is physician underreporting. Many physicians do not report cases of reportable dis- 
eases, including Lyme disease. m 

The second barrier to improved surveillance is resources. In 1991, with federal 
assistance, we were able to hire for the first time an epidemiologist dedicated to 
Lyme disease Surveillance. Our enhanced surveillance activities were largely re- 
sponsible for a 48% increase in the number of reported Lyme disease cases between 
1991 and 1992. 

In the last few years, we have tried to assess the effectiveness of our Lyme dis- 
ease prevention efforts. In a telephone survey of adults done in 1992, 66% of the 
respondents reported they knew "a lot" or "some" about Lyme disease. Only half 
(56%) of these respondents reported that they had taken precautions to prevent 
Lyme disease during the past year. 

Recently, with the assistance of Federal resources, we have been able to develop 
Lyme disease educational videos for primary and secondary school students, our 
evaluation of these materials has not yet been completed, but what I can tell you 
is that 6 months after the video was shown to 9th grade students, much of the 
knowledge gained by these students about Lyme disease was lost. Behavioral 
changes to prevent Lyme disease are difficult to sustain with short stand-alone edu- 
cational interventions. . 

When people ask what they can do to protect themselves from getting Lyme dis- 
ease, we tell them to wear long pants, use a tick repellent, and check themselves 
for ticks. Last summer, we conducted a study in the Lyme, Connecticut area to de- 
termine whether the commonly recommended personal protective measures are ef- 
fective to support the effectiveness of these measures. In my opinion, the use of 
these personal protective measures is unlikely to lead to a decrease in the incidence 
of Lyme disease in areas where Lyme disease is common. This does not mean that 
we should stop urging people to use these measures. But it does mean that we need 
to aggressively pursue the development of more effective preventive measures. 

The best way to move forward on this issue is to develop a national strategic plan 
for the control and prevention of Lyme disease. This plan should define the path 
that will lead us in a timely way to effective primary prevention measures. These 
measures should include tick control measures that work and an effective Lyme dis- 
ease vaccine for humans. Enhanced surveillance for Lyme disease is needed, so that 
the effectiveness of future prevention efforts can be assessed. The strategic plan 
should identify the Federal resources needed to get the iob done. 

We will need continued Federal leadership. I would like to commend the Centers 
for Disease Control and Prevention (CDC) for taking a leadership role in the public 
health response to Lyme disease. CDC's leadership in this area has been especially 
apparent since responsibility for this disease was transferred to the Division of Vec- 
tor-Borne Infectious Diseases, National Center for infectious Diseases in Ft. Collins, 
CO in the fall of 1989. 

I am fully aware that there are other important Lyme disease issues. Many of 
these issues, like the diagnosis and treatment of chronic Lyme disease, can best be 
resolved by well-designea clinical studies, which are needed and should be funded. 
These issues need to be resolved by the clinical medicine community. The public 
health focus should and must be on preventing new cases of Lyme disease. 

Thank you for the opportunity to discuss the public health response to Lyme dis- 
ease. We in Connecticut are grateful for Federal support of our Lyme disease activi- 



66 

ties. I would be more than happy to answer any questions you or other members 
of the committee have. 

Senator Dodd. Dr. Steere. 

Dr. Steere. Thank you very much, Senator Dodd. 

I am Allen Steere, a professor of medicine at New England Medi- 
cal Center, Tufts University School of Medicine in Boston. I di- 
rected the investigation that led to the original description of Lyme 
disease in 1976. 

Since that time, I have directed a Lyme disease clinic now for 17 
years. During that period, I have entered over 1,000 patients into 
Lyme disease studies supported by the extramural program at the 
NIH. 

I want to take this opportunity to say that I am very grateful for 
this support which has made possible all of my work on Lyme dis- 
ease. The results of these studies have been published in the peer- 
reviewed medical literature, and these and other studies were re- 
viewed in the New England Journal of Medicine in 1989. I would 
like to enter this review article into the record of today's testimony 
because it gives a thorough description of the clinical features, di- 
agnosis, and treatment of this illness. 

Senator Dodd. It will be included in the files of the committee. 

Dr. Steere. For the sake of brevity, I would like to stress only 
several points about the clinical manifestations of the illness. Lyme 
disease is a complex infection. However, it typically causes char- 
acteristic clinical symptoms and objective abnormalities in the skin, 
nerves, heart or joints. In about 80 percent of patients, the infec- 
tion begins with an expanding skin lesion called erythema migrans. 
Even the late neurologic involvement of the disease, which causes 
the most nonspecific symptoms, such as memory deficit or numb- 
ness and tingling in tne hands or feet, is usually associated with 
abnormalities on standard neurologic tests. Thus, diagnosis can 
usually be based upon objective clinical criteria. 

In addition to the clinical picture, it is possible to show labora- 
tory evidence of the infection in most patients. It is difficult, how- 
ever, to culture the causative spirochete except from the initial skin 
lesion. Therefore, the only practical laboratory test currently avail- 
able is serologic testing which identifies antibody directed against 
the spirochete. In our studies, and in most other studies, this test 
has been positive in almost all patients after the first several 
weeks of infection. 

Serologic testing for Lyme disease can be done with a high de- 
gree of accuracy even now, but the test is not yet standardized, and 
the performance of the test nationwide is highly variable. Research 
is certainly needed to improve laboratory tests for Lyme disease, 
particularly for the development of tests that detect the spirochete 
or its genes or antigens directly. 

However, improved laboratory tests will not by themselves solve 
the problem of Lyme disease diagnosis. I believe that clinical judg- 
ment will always be necessary. 

Non-neurologic manifestations of Lyme disease can usually be 
treated successfully with oral doxycycline or amoxicillin. These are 
two of the most common and least expensive antibiotics available. 
Nervous system involvement is more difficult to treat, and appro- 
priate regimens are still being worked out. However, in our experi- 



67 

ence and in the experience of other investigators who have pub- 
lished treatment studies in the peer-reviewed medical literature, 30 
days of therapy with intravenous ceftriaxone or penicillin is usually 
sufficient, although in a few patients, or in some patients, the 30- 
day course of therapy may need to be repeated. 

There is no evidence that many months or even years of anti- 
biotic therapy are necessary to eradicate the Lyme disease spiro- 
chete. Because of the success of early antibiotic therapy in acute 
Lyme disease, chronic, active Lyme disease has become an unusual 
illness. However, infection with B. burgdorferi may occasionally 
trigger several puzzling syndromes that appear to continue after 
apparent eradication of the spirochete. A rare syndrome is chronic 
arthritis, usually manifested as swelling of one or both knees, 
which may persist for months after eradication of the spirochete, 
apparently for immune-mediated reasons. In addition, we have re- 
ported, as have others, that infection with B. burgdorferi may trig- 
ger chronic fatigue syndrome or a chronic pain syndrome called 
fibromyalgia. In our experience, these patients are not helped by 
further antibiotic therapy. 

Research efforts to understand the basic mechanisms causing 
these problems are of great importance in Lyme disease and may 
also help in understanding certain other illnesses such as rheu- 
matoid arthritis or fibromyalgia. 

Finally, it is important to point out that chronic Lyme disease 
has become a catch-all diagnosis for a number of confusing and dif- 
ficult-to-treat conditions. Of 788 patients evaluated at our center in 
the last 5 years who were referred with a presumptive diagnosis 
of chronic Lyme disease, we thought that only 23 percent had ac- 
tive infection with B. burgdorferi. We thought that the majority 
had other illnesses, particularly chronic fatigue syndrome or 
fibromyalgia, not triggered by spirochetal infection. 

Contusing active Lyme disease with other illnesses runs the risk 
of taking Lyme disease research efforts down the wrong track and 
wasting scarce resources. The fact that misdiagnosis of chronic 
Lyme disease has become a common problem in no way changes 
the fact that Lyme disease itself is a great problem. I am confident 
that continued research, particularly continued research in basic 
mechanisms of Lyme disease, will result in further improvements 
in our ability to prevent, diagnose and treat this infection.. Contin- 
ued support from the Federal Government is vital to these research 
efforts. 

Thank you. 

[The prepared statement of Dr. Steere follows:] 

Prepared Statement of Allen C. Steere, M.D. 

I am Allen C. Steere, M.D., Professor of Medicine at Tufts University School of 
Medicine in Boston. I directed the investigation that led to the original description 
of Lyme disease in 1976. Since that time, I have directed a Lyme disease clinic, now 
for If years. During that period, I have entered over 1,000 patients into Lyme dis- 
ease studies supported by the extramural program at the NTH. I want to take this 
opportunity to say that I am very grateful ior this support which has made possible 
all of my work on Lyme disease. The results of these studies have been published 
in the peer-reviewed medical literature and were reviewed in the New England 
Journal of Medicine in 1989. I would like to enter this review article into the record 
of today's testimony because it gives a thorough description of the clinical features, 
diagnosis, and treatment of the illness. 



68 

For the sake of brevity, I would like to stress only several points about the clinical 
manifestations of the illness. Lyme disease is a complex infection. However, it typi- 
cally causes characteristic clinical symptoms and objective abnormalities in the skin, 
nerves, heart, or joints. In about 80% of patients, the infection begins with an ex- 
panding skin lesion called erythema migrans. Even the late neurologic Involvement 
of the disease, which causes the most nonspecific symptoms, such as memory deficit 
or numbness and tingling in hands or feet, is usually associated with abnormalities 
on standard neurologic tests. Thus, diagnosis can usually be based upon objective 
clinical criteria. 

In addition to the clinical picture, it is possible to show laboratory evidence of the 
infection in more patients. It is difficult, however, to culture the causative spirochete 
except from the initial skin lesion. Therefore, the only practical laboratory test cur- 
rently available is serologic testing which identifies antibody directed against the 
spirochete. In our studies, this test has been positive In almost all patients after 
the first several weeks of infection. It should be emphasized that serologic testing 
for Lyme disease can be done with a high degree of accuracy, even now; but the 
test is not yet standardized and the performance of the test nationwide Is highly 
variable. Research is certainly needed to improve laboratory tests for Lyme disease, 
particularly for the development of tests that detect the spirochete or its genes or 
antigens directly. However, improved laboratory tests will not by themselves solve 
the problem of Lyme disease diagnosis. I believe that clinical judgment will always 
be necessary. 

Lyme disease can usually be treated successfully with oral doxycycline or 
amoxicillin. These are two of the most common and least expensive antibiotics avail- 
able. Ten days of therapy is generally sufficient for infection localized to the skin, 
but 30 days is often required for disseminated infection. Nervous system involve- 
ment is more difficult to treat and appropriate regimens are still being worked out. 
In our experience and in the experience of other Investigators who have published 
treatment studies in the peer-reviewed medical literature, 30 days of therapy with 
intravenous ceftriaxone or penicillin is usually sufficient, although in a few patients, 
the 30-day course of therapy may need to be repeated once. There is no evidence 
that many months or even years of antibiotic therapy are necessary to eradicate the 
Lyme disease spirochete. Because of the success of early antibiotic therapy in acute 
Lyme disease, chronic Lyme disease has become an unusual illness. 

However, infection with B. burgdorferi may trigger several puzzling syndromes 
that may continue after eradication of the spirochete. One is chronic swelling of the 
knees which may persist for months after eradication of the spirochete, apparently 
for immune-mediated reasons. In addition, we have reported that infection with B. 
burgdorferi may trigger chronic fatigue syndrome or a chronic pain syndrome called 
fibromyalgia. In our experience, these patients are not helped by further antibiotic 
therapy. 

Finally, it is important to point out that chronic Lyme disease has become a 
"catchall" diagnosis for a number of confusing and difficult-to-treat conditions. Of 
788 patients evaluated at our center in the last 5 years who were referred with a 
presumptive diagnosis of chronic Lyme disease, we thought that only 23 percent had 
active infection with B. burgdorferi. We thought that the majority had other ill- 
nesses, particularly chronic fatigue syndrome or fibromyalgia not triggered by spiro- 
chetal infection. Confusing active Lyme disease with other illnesses runs the risk 
of taking Lyme disease research efforts down the wrong track and wasting scarce 
resources. 

The fact that misdiagnosis of "chronic Lyme disease" has become a common prob- 
lem in no way changes the fact that Lyme disease itself is a problem. I am confident 
that continued research into the basic mechanisms of Lyme disease will result in 
improvements in our ability to prevent, diagnose, and treat this infection and may 
also give clues for research in several other puzzling diseases of unknown cause 
such as rheumatoid arthritis or fibromyalgia. Continued support from the Federal 
government is vital for these research efforts. 

Senator Dodd. Thank you very much, Dr. Steere, for that testi- 
mony. 

You may have touched on this earlier, but I am struck by the 
fact that we have seen a number of instances, including Karen 
Forschner who testified earlier, of a family, including every pet, 
being infected. The medical evidence suggests that this is not a 
communicable disease. And yet there seem to be a number of cases 
which would run contrary to that particular notion. How do you re- 



69 

spond to that? We've got a whole panel of physicians here, so any- 
body who wants to answer may. 

Dr. Burrascano. I think that by and large, case clusters are due 
to common exposure. But one very important point to be made 
today is that there is no study that I know of being funded by the 
Government to study person-to person transmission. 

The reason why I bring that up — even though I personally don't 
think that occurs based on my survey of mv patients — is because 
when I do Lyme engagements, where I speak to lay groups, which 
I do quite often, one of the questions I am asked over and over and 
over again is: Is there sexual transmission of Lyme disease? And 
I have to say I don't know, because that type of research has not 
been done. 

So that's iust one example of the fact that there are many, many 
unanswered questions, and relevant ones, too. 

Senator Dodd. Let me just ask you now, based on what you 
know as a physician, is it warranted for us to do that kind of test? 
Dr. Burrascano. I think it would be wise, yes. 
Senator Dodd. Do other members of the panel wish to comment? 
Dr. Cartter. I'd like to point out that if you are in Lyme, CT 
and step outside your door, not only will you find ticks, but 20 per- 
cent of them will be infected with the spirochete that causes this 
disease. And certainly, many people and families have had this dis- 
ease as a result of a common exposure to a tick. 

If you look at the epidemiology, it is quite clear that the predomi- 
nant mode of transmission for those disease is through a tick bite. 
Senator Dodd. So you don't subscribe to the notion that this is 
communicable through any other form of contact? 

Dr. Cartter. The epidemiology does not support transmission 
from person to person. 
Senator Dodd. Dr. Steere. 

Dr. Steere. I have also done epidemiologic studies of this dis- 
ease, including the original epidemiologic study which identified 
Lyme disease, and the pattern of transmission looks like arthropod- 
borne transmission because when one looks at a population of pa- 
tients, it looks like hit-and-miss acquisition of the disease. 

There are families where multiple members have had the onset 
at the same period, but it has been difficult to trace a pattern 
through the family. With a person-to-person-transmitted disease, 
one person gets it, then the next person gets it, and so on. There 
is passage that you can usually identify, and that has not been the 
case with Lyme disease. 

Senator Dodd. OK But going back to the point of where we focus 
resources — and I think everybody here seems to understand and 
appreciate it^-I'm going to ask all of you to give us specifically 
what you would like the Congress or the Federal Government to 
do, specifically where you'd Tike to see us focus our attention. 
Karen talked about marshalling resources and coordinating the 
various well-intentioned activities going on at various levels of Gov- 
ernment. 

Is this is an area where we ought to put some dollars? Do I hear 
you saying is that there doesn't seem to be enough evidence to war- 
rant this as a high priority? 



70 

Senator Durenberger. Mr. Chairman, while they think about it, 
would you favor me with a one-minute comment? 

Senator Dodd. Just let me get an answer to this, and I'd be glad 
to. 

Do you think we ought to spend money on it? 

Dr. Steere. Yes, absolutely. I think tnat Lyme disease is a great 
problem, and I think studies of it, particularly basic mechanisms 
of the disease, are of great importance. And I think that's what is 
most likely to help. 

Senator Dodd. Dr. Cartter. 

Dr. Cartter. I think in public health, prevention always pays 
off, and I think the emphasis should be on prevention of this dis- 
ease. 

Senator Dodd. Mr. Piatt. 

Mr. Platt. I would agree; I think prevention is the number one 
problem. 

Dr. Burrascano. When it comes to directing funds for research, 
which are scarce, there are several points that should be empha- 
sized. No. 1 is realistic and widespread required reporting criteria 
that are reasonable and accurate in terms of what is out there in 
the real world. The other is a better diagnostic test, not just for 
making the diagnosis, but for detecting if the spirochete is still 
present in someone before, during, and after treatment. 

So there are two goals. No. 1 is better surveillance, and number 
two is better testing. 

Senator Dodd. Howard. 

Senator Metzenbaum. Thank you, Mr. Chairman. I have a cou- 
ple questions. 

Dr. Steere, I gather that the diagnosis of Lyme disease is not 
that fully developed that the physicians around the country really 
know enough about it or know enough about how to make the diag- 
nosis. Is that the thrust of what you are saying? 

Dr. Steere. I think that there are objective clinical criteria. I 
also think that it is possible to have laboratory tests that can help 
support that diagnosis. But nationwide, there is no standardization 
of that type of testing. 

There is certainly a great need for education, including education 
of physicians, about what this disease is and what it is like. And 
certainly, further research is needed to define that even more. 

Senator Metzenbaum. I remember when one of our fellow Mem- 
bers of Congress was diagnosed as having Lyme disease, Berkeley 
Bidell, a fine member of this body, and he resigned — or stepped out 
and didn't run for re-election; I guess he didn't actually resign — be- 
cause he thought he had Lyme disease, and subsequently found he 
did not. 

I get the feeling that across this broad United States, if you go 
to see Dr. Steere or one of these other gentlemen here, that you 
probably can get an accurate answer, but that there is a reasonable 
chance that if you go to many other doctors in the country — and 
this is not a broad-brush condemnation of them — but that it is not 
easily diagnosed and not easily diagnosed even after laboratory 
tests, unless the laboratories are particularly prepared for this kind 
of diagnosis. 

Now, am I misinterpreting what you are saying? 



71 

Dr. Steere. No. I think that is absolutely true and very well- 

stated 

Senator Metzenbaum. So therefore we have the problem of how 
we get the education out and how we get the diagnosis out. 

Now with respect to the treatment, you mentioned two particular 
products that can be used— I forget what they were; I'm sure you 
know what they are — with oral 

Dr. Steere. Oral therapy with doxycycline, a tetracycline type of 
antibiotic, and amoxicillin, a penicillin type of antibiotic. 

Senator Metzenbaum. And how effective is that? 

Dr. Steere. Well, I think for nonneurologic manifestations of the 
disease, they are quite effective. Neurologic manifestations of the 
disease are harder to treat, and how best to treat them is still 
being worked out. 

Senator Metzenbaum. Would you consider arthritis a neurologic 

kind of illness? 

Dr. Steere. I would consider arthritis a musculoskeletal type of 
involvement. So in Lyme disease, one gets inflammation of the lin- 
ing of the joint because initially, the spirochete is there; so that's 
the reason for it. One can kill the spirochete being there with ap- 
propriate antibiotic therapy. 

Senator Metzenbaum. I get the feeling as I sit here that this is 
a challenging medical problem, but actually not so challenging if 
we just put a little bit more push behind it and help the members 
of the medical profession know more about it, to be able to do bet- 
ter diagnosis, better educate at the laboratories, and then better 
educate the physicians as to what kind of treatment does work and 
what doesn't. I get the feeling that it isn't like cancer, where we 
don't have any answer at all, and we don't know what to do — the 
cancer is there, and it just growsi — and some other illnesses. 

Dr. Steere. Again, I totally agree and think that is very well- 
stated. Lyme disease is a disease of known cause. In contrast, most 
of the rheumatic diseases, most of the other types of arthritis, are 
not of known cause. Therefore, there is much greater possibility for 
doing something to help with Lyme disease. 

Also, by learning more about Lyme disease and its basic mecha- 
nisms, it may indeed help us understand some of these other very 
puzzling illnesses where we don't know the cause, like rheumatoid 
arthritis, like multiple sclerosis. 

So I want to emphasize very much that I believe you are abso- 
lutely right that research on Lyme disease, that education, preven- 
tion — this is something we can do something about. 

Senator Metzenbaum. Let me change the thrust a little bit. Dr. 
Cartter, you are head of the program in the State of Connecticut. 
What about the possibility of developing some sort of a spray, some 
way of going after the basic problem at the level of the deer itself, 
whether that makes any sense? Is there some way we can do some- 
thing to destroy the ticks? 

Dr. Cartter. Until recently, methods to control the tick were not 
very effective. I think the folks from the CDC will be talking about 
some new research that suggests that the use of pesticides for resi- 
dential areas may well be effective for a season. This is relatively 
new information that was only recently made available. If that's 
the case, we may have better ways to actually control the tick. 



72 

But I would like to point out that there are often community con- 
cerns about the use of pesticides, so there is a balance that has to 
DC made out there in trie community, risk of Lyme disease versus 
risk of pesticides. 

Senator Mktzknbaum. As I understand it, the ticks that may be 
picked up have been infected while on the deer, but then they don't 
remain on the deer; they move around, or fly around, I guess — is 
that pretty accurate? 

Dr. CARTTER. Well, the ticks are actually infected as a result of 
being on white-footed mice, at least in our area, not the deer. And 
the entomologists tell us that you virtually have to eliminate deer 
populations to have a marked effect on the tick population. Again, 
politics plays into this, and there are strong forces at work to pre- 
vent that kind of deer control strategy. 

Senator METZENBAUM. Well, thats a rather drastic approach to 
eliminate all the deer. Do you mean to say — I guess you are say- 
ing that there are some means of dealing with the problem with- 
out actually killing all the deer. 

Dr. CARTTER. The whole thrust of my testimony was that the 
things that we have been recommending for 17 years do not have 
a marked effect on decreasing Lyme disease incidence, and we need 
better ways We need better ways in terms of controlling the tick. 
There may be some recent breakthroughs, but we don't have them 
yet. And we need > human vaccine against this disease. 

Senator METZENBAUM. Thank you. 

Senator DODD. Thank you. I'm sorry, Dr. Burrascano, you want- 
ed to comment. 

Dr. BuRKAiSf.ANO. Yes. I did want to respond to some of the ques- 
tions that just came before, especially to Senator Metzenbaum. 

I don't want you to get the impression that Lyme disease is very 
simple It is a very difficult illness to diagnose. The blood test is 
not reliable enough to use as a diagnostic tool. The clinical picture 
is not 

Senator METZENBAUM. This gentleman says exactly the opposite 
of what you said. |Anplause.| 

Senator DODD. Please, please, let's maintain order. This is a 
hearing. 

(\<> ahead, Doctor. 

Dr. BURRASCANO. Vm sorry. The Lyme disease diagnostic test is 
known to be not 100 percent accurate. There aro scientific reports 
in published medical journals showing patients who had confirmed 
Lyme disease who did not test positive on this test. Many of the 
patient! who testified today as well as in the audience who later 
went on to l>e proven unequivocally to have the infection never 
tested positive on this very same type of tost. 

Studies where this type of test was compared from lab to lab to 
lab found that the agreement rat<- among labs was so low that the 
test basically did not even pail statistical significance as being ac- 
curate at all. 

So simplification number one that you should avoid is that it is 
easy to diagnose, because it is not. 

Senator DODD. Well, let me just stop you right then?. Dr. Steere 
talked about and I wrote down the word — serological testing. 

Dr STKERE. That's correct 



73 

Senator Dodd. And you said that it's a good test, not a perfect 
test, but a pretty good test. Am I paraphrasing your remarks accu- 
rately? 

Dr. Steere. Yes, I believe that's right 

Senator DODD. How do you respond to this? Do you disagree with 
Dr. Steere on that point? 

Dr. BURRASCANO. I disagree for several reasons. First of all. my 
own clinical practice involves patients from 38 States and 8 dit 
ferent countries over the last 8 to 10 years, thousands of patients. 
many of whom did see 10, 20, 30, 4(5, 50 different doctors before 
they were diagnosed because the doctors said, "You have a negative 
blood test; you don't have Lyme disease." 

So my perspective is a little bit different than Dr. Steere, who 
requires a positive test before being entered into his studies. So 
there is a statistical glitch there. If you actually look at the real 
world of Lyme disease, you'll find that at least 20 if not 30 percent 
of people who have Lyme disease do not show positive on this sero 
logic blood test. There are many explanations for that now in the 
medical literature. 

Senator Dodd. Dr. Steere. 

Dr. STEERE. I stand by the studies that 1 have done and the 
other studies that are in the medical literature. 1 also agree that 
there is an entity called "sero negative Lyme disease." and I have 
published on that entity. 1 agree that there are patients who do not 
have a positive serologic test late in the illness, but I think it is 
rare. We see about one such patient a year. I understand at 
Stoneybrook, which is another major center, that they see about 
one 

Senator Dodd. Please, this is a hearing, a congressional hearing. 
Editorial comment from the audience is not appropriate. 

Go ahead, Dr. Steere. 

Dr. STEERE. I understand at Stoneybrook, that it is also the case 
that they see about one such patient a year. It also seems to be 
important in that entity that the patient has received early anti 
biotic therapy. 

So yes, 1 agree, sero negative Lyme disease exists, but 1 think it 
is rare. 

Senator Dodd. Dr. Burrascano. 

Dr. BURRASCANO. The second point 1 wanted to address was the 
Simplification of the treatment ot Lyme disease Many patients who 
have been diagnosed after the disease has been present for more 
than just a short period of time, those who have had the illness for 
several months to several years before diagnosis, very often are not 
returned back to normal with antibiotic therapy as we know it 

today. 

One of the problems is that we don't know why people remain 
ill. We pretty much rocognr/.o that a lot of people will remain ill 
after Short courses of antibiotic therapy when they have late dis 
seminal ed Lyme disease. The controversy which 1 tried to address 
today in my (eslunonv is that we don't know why. 

There is an establishment of physicians university based who 
claim that the 30 days of treatment cures the patients; anything 
that is lefl-over has to be some arthritic phenomenon or some- 
thing they don't knew what it is and they sluiMe the patients off 



74 

to a chronic fatigue clinic or to a fibromyalgia clinic. Yet there have 
now been many, many studies showing that these people still have 
the infection. 

So apparently, the infection can persist and evade the effects of 
antibiotics, and the presence of the organism somehow drives this 
reaction to keep the people sick. 

I have here an electron micrograph, a photograph of the spiro- 
chete, done by the NIH's lab at Rocky Mountain. This was taken 
from the urine of a patient who remained ill after one and a half 
years of antibiotics. This spirochete was identified positively as B. 
burgdorferi, the causative agent for Lyme disease. So in this one 
patient — and again, there are patients that you might see in the 
audience or who have testified today who are in a similar situa- 
tion — for them, the antibiotic therapy did not work. 

So what I am saying is that we need to focus our research on 
the real world of Lyme disease. No. 1, diagnosis is not simple or 
clear; the diagnostic test is not 100 percent. We need better testing. 
No. 2, treatment strategies as you might find in New England 
Journal articles are very basic minimums and do not cover the 
more chronic patients or those who are more seriously ill, and 
these chronic patients are not now being studied systematically for 
infection, and they should be. 

Senator Dodd. OK. 

Senator Metzenbaum. Mr. Chairman, could I just ask Dr. 
Burrascano — I am not clear on something. You talked about your 
patients, but do I understand you to be a veterinarian? 

Dr. Burrascano. No. I am an internist. 

Senator Dodd. Howard, the name plates aren't quite clear. Dr. 
Piatt is a veterinarian. 

Senator Metzenbaum. OK. Thank you. 

Mr. Hochbrueckner. Mr. Chairman, if I could 

Senator Dodd. Very briefly, yes. 

Mr. Hochbrueckner. — if I could again raise the issue that we 
touched on before in terms of the personal protection. There is no 
question that we don't expect that a young child would get 97 per- 
cent protection as you would with an Army person who is following 
direction. But the fact of the matter is that certainly, we have to 
do all of these things, but anything we can do to help people not 
get the disease by keeping the tick off the person, whether it is a 
spray on the clothing or the deep-based lotion on the skin, obvi- 
ously is important. 

I would request, could we perhaps hear from Karen Forschner for 
a one-minute response to some of the things that have been said 
here? 

Senator Dodd. We have another panel to hear from, so I want 
to try to move along. But Karen will have a chance to submit fur- 
ther comments on this. 

Mr. Hochbrueckner. Very good. Thank you. 

Senator Dodo. I just want to ask about the educational efforts, 
if I can, and to what extent they exist. Now, in Connecticut, I think 
they are pretty good. On television, there seem to be a lot of an- 
nouncements warning people in the summer months about what to 
be careful of and so forth. I don't know how extensive that is na- 



75 

tionwide, and to what extent medical journals and traditional ma- 
terials inform doctors about signs to be looking for in patients. 

Is there a broad enough and effective enough educational pro- 
gram out there dealing with prevention? Is there broad enough 
awareness nationwide of what people ought to be looking for, what 
doctors ought to be looking for, what patients ought to De looking 
for in the early detection of this disease? 

Dr. Cartter. I'd like to address that issue of education. In terms 
of education of physicians, certainly more can be done. We have 
done a lot in Connecticut. There needs to be more in other States 
where Lyme disease is much less common. 

In terms of educating the public, I did not mean to imply that 
we should stop educating people about preventive measures. I 
think the important thing to point out is that in practice, the 
things that we have been recommending to people are probably not 
very effective. We have to stop pretending that they are so that we 
can drive toward more effective preventive measures. 

Senator Dodd. Is there any other comment on that particular 
question? Do you all agree that more needs to be done on the edu- 
cational efforts? 

Dr. Burrascano. New York State a number of years ago had a 
direct mailing to all licensed physicians in New York that outlined 
the manifestations, diagnosis, and suggestions for treatment of 
Lyme disease. I thought that was a very good program, but it only 
occurred once several years ago. And such a program, which is a 
single, one- or two-page brochure, I think would really be helpful 
to nationally distribute. 

Senator Dodd. Let me ask about the difference in how the dis- 
ease manifests itself in adults and children. You have talked about 
the dangers to children because of their level of energy and activity 
and what they do. But from a medical standpoint, is there a dif- 
ference in terms of how this disease manifests itself in children and 
adults? 

Dr. Steere. Our studies suggest that there are very similar 
manifestations, with the possible exception that in very young chil- 
dren age 2 to 4, the illness may be milder. In general, with a num- 
ber of infectious disease — Epstein-Barr virus infection would be an 
example which is milder as a generalization in young children than 
in older children or adults. 

Senator Dodd. Dr. Cartter, do you agree? 

Dr. Cartter. Yes. 

Senator Dodd. Does anyone disagree with that last statement? 

Dr. Burrascano. I don't disagree, but I want to make one com- 
ment which is interesting. We have noticed that when children be- 
come hormonally active — when the girls and boys become 10, 11, 
12 years old — the illness, if it is not arrested properly, if they have 
not been diagnosed, their illness can very often take a turn for the 
worse. You saw one child here today who had that same thing hap- 
pen. 

What we physicians in the field would like to see is some type 
of a program for children's Lyme disease issues, perhaps run by the 
NIH, where these specific problems could be more carefully ad- 
dressed. 

Senator Dodd. Thank you. 



76 

I would invite all of you — Karen, as well as other witnesses on 
the first panel — to comment on anything you have heard here as 
part of the record today. And we may submit some additional ques- 
tions to you in writing from other committee members who were 
unavoidably absent this morning. 

I thank all of you very, very much for being here. I appreciate 
your time. 

Our third and last panel is composed of experts in the study of 
infectious diseases. Dr. Joseph McDade is the associate director of 
laboratory science at the National Center for Infectious Disease at 
the CDC, and Dr. John LaMontagne is director of the Division of 
Microbiology and Infectious Diseases at the National Institute of 
Allergy and Infectious Diseases at the NIH. 

I thank both of you for being here, and thank you for being pa- 
tient with us this morning as we went through our first two panels. 
Again, I won't ask you to live by this timer religiously, but if you'd 
try to keep an eye on it, we'll be glad to accept your complete writ- 
ten testimony and any supporting documentation or data you think 
would be worthwhile for the committee to have in its consideration 
of the hearing this morning. 

Dr. McDade, we'll begin with you. 

STATEMENTS OF DR. JOSEPH McDADE, ASSOCIATE DIRECTOR 
OF LABORATORY SCIENCE, NATIONAL CENTER FOR INFEC- 
TIOUS DISEASES, CENTERS FOR DISEASE CONTROL AND 
PREVENTION, ATLANTA, GA; AND JOHN R. LAMONTAGNE, DI- 
RECTOR, DIVISION OF MICROBIOLOGY AND INFECTIOUS 
DISEASES, NATIONAL INSTITUTE OF ALLERGY AND INFEC- 
TIOUS DISEASES, NATIONAL INSTITUTES OF HEALTH, BE- 
THESDA,MD 

Dr. McDade. I am Dr. Joseph McDade, associate director for lab- 
oratory science, National Center for Infectious Diseases, Centers 
for Disease Control and Prevention. 

I am pleased to respond to the committee's invitation to discuss 
national Lyme disease surveillance and CDC's role in prevention 
and control of Lyme disease in the United States. I will briefly 
highlight CDC's Lyme disease program and describe some of our 
research efforts to develop improved strategies for prevention and 
control of this important disease. 

Lyme disease is an emerging infectious disease. The recent Insti- 
tute of Medicine report, "Emerging Infections, Microbial Threats to 
Health in the United States," identifies six factors which can lead 
to emerging microbial threats. Two of these factors — changes in 
land use, and erosion of the public health infrastructure — are rel- 
evant to the continuing spread of Lyme disease in the United 
States. 

Mr. Chairman, I would like to submit a copy of the executive 
summary of the IOM report for the record. 

Senator Dodd. Without objection. 

[ The report referred to is retained in the files of the committee.] 

Dr. McDade. Lyme disease is an important and preventable pub- 
lic health problem. More than 9,600 cases of Lyme disease were re- 
ported by 45 State health departments to CDC in 1992. The figure 



77 

is a 19-fold increase from the 497 cases reported by 11 States in 
1982. 

Confirming a case of Lyme disease can be difficult. Signs and 
symptoms of Lyme disease are often diverse, and many laboratory 
tests show negative results in early Lyme disease. For diagnosis of 
patients with untreated late Lyme disease, available laboratory 
tests are sometimes more accurate and more reliable. Improved 
laboratory tests are being developed and standardized. 

CDC as the Nation's prevention agency is leading the Nation's ef- 
forts to develop a comprehensive, science-based public health pro- 
gram for Lyme disease prevention and control, including surveil- 
lance, epidemiologic investigations, improving methods of diag- 
nosis, ecologic studies, and education programs. CDC has developed 
intramural and extramural Lyme disease programs that address 
these components. 

The Lyme disease program at CDC has been funded by congres- 
sional appropriations of approximately $5.5 million annually dur- 
ing the period 1991 through 1993. Approximately $3 million of 
these appropriations have been awarded annually to State and 
local health departments, private nonprofit foundations, and uni- 
versities through cooperative agreements and contracts. I will brief- 
ly describe five aspects of this program. 

First, national surveillance of Lyme disease. In 1982, CDC began 
a systematic collection of numbers of cases of Lyme disease re- 
ported to State health departments. The authority to make a dis- 
ease notifiable rests with the States. State health departments de- 
termine which diseases must be reported to them, and through the 
Council of State and Territorial Epidemiologists, or CSTE, which 
diseases the States will report to CDC. 

In 1990, CSTE adopted a uniform surveillance case definition for 
Lyme disease and approved a resolution making Lyme disease na- 
tionally reportable beginning in 1991. 

CDC's Lyme disease case definition was developed specifically for 
public health surveillance of cases and not for purposes of clinical 
diagnosis or determination of health insurance or medical disability 
benefits. 

In March 1993, a meeting of outside scientific consultants was 
convened to review the surveillance case definition. The consult- 
ants included representatives of CSTE, other public health person- 
nel, clinicians and laboratorians. The participants carefully re- 
viewed all clinical and laboratory components of the current defini- 
tion and assessed our experience using the case definition. As a re- 
sult of these and subsequent discussions, CDC recommended to 
CSTE that no changes be made in the current surveillance case 
definition, and there are no current plans to revise the surveillance 
case definition. 

Active surveillance has been supported in some areas by CDC co- 
operative agreements. In 1992, the number of reported cases in 
Connecticut and Rhode Island detected by active surveillance in- 
creased 48 percent and 93 percent, respectively, over 1991. In con- 
trast, New York reported a 15 percent decrease of cases from 1991. 
This decrease in reported cases occurred following reductions in 
State and county surveillance personnel. 



78 

The need for improved surveillance for Lyme disease and many 
other infectious diseases cannot be overstated. 

Second, epidemiologic investigations. CDC has responded to a 
number of State health department requests for assistance with 
epidemiologic investigations of Lyme disease. 

Senator Dodd. Doctor, you've got about 8 pages left. I am just 
wondering if you might be able to 

Senator Metzenbaum. Why don't you just tell us what is the 
thrust of what you are doing? 

Senator Dodd. Yes. Just talk to us up here and tell us what you 
think. 

Senator Metzenbaum. Talk to us rather than read to us. We'll 
go back and read the whole statement. 

Dr. McDade. I'd be pleased to. 

Senator Dodd. And by the way, I should point out that Dr. 
McDade has a distinguished career and is probably best-known to 
people who follow things like this as the individual responsible for 
discovering Legionnaire's disease. We commend you immensely for 
your efforts. 

And I do apologize for interrupting you, but we want to hear 
what you think. You know this subject really well, and my col- 
league from Ohio is a lot better-informed on these matters than I. 
Talk to me as you would talk to someone who has just arrived here 
and wants to know in layman's terms what you know about this. 

Dr. McDade. I certainly will do that. I think that the most im- 
portant problem that we have is a lack of recognition of Lyme dis- 
ease by the average physician. A recent CDC study in a north- 
eastern State showed that 82 percent of the cases of Lyme disease 
were reported by 7 percent of the physicians. 

Now, there are different ways of interpreting this data, but this 
was from a State in which trie disease is broadly endemic, and 
what that suggests is 

Senator Dodd. Which State are we talking about? 

Dr. McDade. Connecticut. 

Senator Dodd. I was afraid of that. [Laughter.] There are a lot 
of States in the Northeast, and so I was hoping 

Dr. McDade. It is not meant at all as an indictment of Connecti- 
cut. It probably reflects the situation nationwide, which is that ei- 
ther people are not reporting Lyme disease, or they aren't recogniz- 
ing it. And if they are not recognizing it, and they are not treating 
it early — and you have heard adequate testimony to this point — we 
have a serious problem. 

So to my mind, the physician awareness and education of the 
professionals is a key critical component, one that we have been 
working on and that needs a lot more attention. 

The second problem is one of diagnosis. This has been adequately 
documented and today, in testimony from a number of panelists, 
and clearly what it amounts to is a need for increased standardiza- 
tion and there is a need for increased research. CDC has been 
working in the last several months with the Association of State 
and Territorial Public Health Laboratory Directors to standardize 
some of the existing methodology, and that is currently under eval- 
uation. 



79 

Senator Dodd. Could you just comment quickly about the dis- 
agreement we had on that particular point between Dr. Steere and 
Dr. Burrascano? 

Dr. McDade. Well, again, the last thing you want to do is get 
into a fight between two distinguished physicians, particularly 
when you are not a physician. But I think the point is that every- 
one recognizes that there are some deficiencies in the diagnostic 
criteria. The point is where do we go from here. I think there are 
in fact two different kinds of deficiencies. One is the lack of stand- 
ardization in evaluation of the existing methodologies. As I indi- 
cated, we have been working with the Association of State and Ter- 
ritorial Laboratory Directors to standardize what we have so that 
we can at least look uniformly across the States. 

Clearly, there are also many other things that are on the horizon 
that are being studied both by CDC intramurally, our extramural 
program, the NIH extramural program, which offer a lot of better 
alternatives. 

What wasn't perhaps said in some detail, without going into de- 
tails of the science, is that we are dealing with a very worthy ad- 
versary in B. burgdorferi. There are multiple strains of this orga- 
nism; it undergoes antigenic variation, and any diagnostic test that 
you have is going to be fraught with some difficulties. So this is not 
an easy problem, and everyone who is doing research on this recog- 
nizes these problems and is working toward them. But clearly, 
what we need to do is to employ our best efforts to try to find out 
which ones are there and which ones work in a real life situation. 

It is a long way from the laboratory to the field, and an evalua- 
tion by the average public health microbiologist, and those are the 
sorts of things we have to promote. 

The third area is steps toward prevention and control. I think 
the people who talk about walking out their doors and coming into 
almost direct contact with spirochete-infected ticks is absolutely 
true. CDC has been working in some cooperative agreements with 
various States to evaluate various methodologies, integrated ap- 
proaches, that might perhaps be effective, and we are trying to 
evaluate those again in a real life setting— integrated to the extent 
of what is the effect of not only the regional application of insecti- 
cides, plus clearing out the brush, reducing harborage for rodents 
and otner forms of wildlife, even the possibility of the fencing for 
excluding deer — are those effect, or are they not? It takes time to 
evaluate that, but it is a very important concept. 

Also, the continued effect of active surveillance is one which we 
cannot overstate. It goes back to the education as well, but it is 
also surveillance. In those States where people have actively looked 
for cases of Lyme disease, the numbers of cases have doubled; and 
where they have not looked, the numbers have gone down. We are 
not interested in developing case counts. What we are interested in 
knowing is exactly where the disease is — not at the State level or 
at the county level, but at the local level — so that your education 
strategies and your prevention and control strategies can be specifi- 
cally targeted to neighborhoods, regions, and so on because as peo- 
ple have indicated, while there are prospects of a vaccine and they 
are in study, they are on the horizon. 
Finally, let me sum up 



80 

Senator Dodd. On that point, you have triggered a question. 

Dr. McDade. Yes. 

Senator Dodd. In your mind, is there a direct relationship be- 
tween spending more dollars here and getting to that horizon more 
quickly? I have come to learn in this area, not this particular case, 
that more dollars doesn't necessarily mean you get to an answer 
quicker. In this case, I'd like to know whether, in your professional 
capacity, you think investing more would actually get us to that 
point. 

Dr. McDade. I have never known of anyone who has a program 
that couldn't use more. I can't say that you would get a one-to-one 
return on your investment, but I think there is certainly ample 
room for growth where you would get a very goodly return on your 
investment, yes. 

Senator Dodd. Thank you. 

Senator Metzenbaum. Doctor, can I ask you, has CDC done any- 
thing about notifying the doctors of this country what to look for 
with respect to Lyme disease and what kind of testing is suggested 
in order to deal with it? 

I get the feeling that some doctors know about this, but there are 
a hell of a lot of doctors out there who don't know anything about 
it and just sort of push along. Am I wrong about that? Are you pro- 
viding information, or what is the fact? 

Dr. McDade. I think education is coming from a variety of 
sources, as was indicated earlier. For education of children, one of 
our cooperative agreements with the Lyme Disease Foundation — 
they have reached millions of people. Also, I can provide for the 
record if you like a list of the extramural funding; there are some 
half dozen various projects that are targeted directly or indirectly 
toward physician education. That is not to mention the general lit- 
erature, three or four articles published weekly by our Morbidity 
and Mortality Weekly Report, that address various issues, be they 
clinical, epidemiologic, prevention and control. 

There are a number of different approaches that are used. But 
as I'm sure you well can realize, any message that you might try 
to deliver, be it in the commercial sector, private sector, education- 
ally, or in medical, it is sometimes very difficult to reach 100 per- 
cent of the population, and it becomes more costly as you try to get 
100 percent awareness. 

Senator Metzenbaum. What I understand you to say is that doc- 
tors can find this information in a lot of places — in the journals and 
the medical literature— but that the Centers for Disease Control it- 
self has really — I think all of those hit a certain portion of the doc- 
tors of the country — but it seems to me that the CDC, without 
spending a fantastic amount of money, could do a much more effec- 
tive job of really getting to all the doctors in the country. 

Dr. McDade. We certainly don't at all think, Senator, that what 
we have done is enough, and we will continue to look at other ap- 
proaches and other venues in order to try to leverage resources to 
be able to reach the people maximally. I think that's about the 
most general way that I can State it. 

We are very aware not only of what we have done, but more 
aware of what we have not done. 



81 

Senator Metzenbaum. As I sit here, I get the feeling that this 
is a very challenging kind of illness or disease, but the fact is there 
is much more that can be done about it than we can do about a 
number of other illnesses, whether it is cancer or some other dis- 
ease of that kind. And what is bothering me is that I just have the 
feeling that there is a gap where the physicians in the field are 
really not up-to-speed as to diagnosis and treatment. And I think 
Dr. Steere pretty much confirmed that. And I think CDC is the 
agency to which we in Congress would look to ask, don't you have 
a greater responsibility than that which you are presently doing. 

Dr. McDade. I can say that your statement is entirely accurate, 
and CDC would love to have the opportunity to meet that chal- 
lenge. 

Senator Metzenbaum. If you need help in doing it, I think you 
ought to let us know. 

Senator Dodd. I think he just did when asked about the money. 

Senator Metzenbaum. Well, I got the feeling, if you remember 
his response to you 

Dr. McDade. I think the answer to your question is yes. 

Senator Metzenbaum [continuing.] was that you can always use 
more; but I didn't get the feeling that they couldn't do it with that 
which they have. And that is 

Dr. McDade. Realize that our active surveillance programs with 
what we have done have been a pilot study, and the pilot study is 
conducted in order to determine whether what you are doing is ef- 
fective at a nominal cost. And if it turns out that it is effective, 
then clearly what you want to do is expand that to other areas. 
That is the State that we are now. 

Senator Dodd. Why don't we use this opportunity to request 
that, in the next couple of weeks, or during this month of August, 
you submit to this committee a recommendation of dollar amounts 
and how you would like to see them spent in order to deal with the 
very issue that Senator Metzenbaum nas raised here today so that 
we might have an opportunity to talk to our colleagues and look 
at the issue during this appropriation cycle. We'd like to have solid 
information from the agencies and groups we have to rely on. We 
turn to you guys on these kinds of questions, and I think it would 
be helpful. Howard, I don't know if you agree with that or not. 

Senator Metzenbaum. I do. As I see it, the CDC only gets, I'm 
told, $3 million a year? 

Dr. McDade. No. I believe the appropriation last year finally be- 
came $5.1 million, reduced by the amount that went to the States, 
which was just under $3 million. 

Senator Dodd. So about $3 million goes to the States. 

Dr. McDade. CDC would be pleased to provide that additional 
information. We have considered it before, and I think it would 
take us just a short time to be able to review those documents and 
provide them to the committee. 

Senator Dodd. I don't want to put a time pressure on you, but 
in September, the appropriations bills are upon us. If we don't get 
your recommendation in time, you might wait another whole fiscal 
year unless you can get some kind of emergency supplemental ap- 
propriation. 
Thank you, Dr. McDade. 



82 

[The prepared statement of Dr. McDade follows:] 

Prepared Statement of Joseph McDade, M.D. 

I am Joseph McDade , M.D., Assoc. Dir. of Lab Science, Nat. Cntr. for Infectious 
Diseases (NCID), Centers for Disease Control and Prevention (CDC). I am accom- 
panied by Duane J. Gubler, D.Sc., Director, Division of Vector-Borne Infectious Dis- 
eases, NCID, CDC. I am pleased to respond to the committee's invitation to discuss 
Lyme disease surveillance and CDC's role in prevention and control of Lyme disease 
in the United States. I will review the CDC s Lyme disease program and describe 
the research efforts to develop improved strategies for prevention and control of this 
important disease. 

Lyme disease is an emerging infectious disease. The recent Institute of Medicine 
(IOM) report, "Emerging Infections, Microbial Threats to Health in the United 
States," identifies six factors which can lead to emerging microbial threats — changes 
in demographics and behavior, technologic advances, economic development and 
land use, international travel and trade, microbial adaptation, and a breakdown of 
public health measures — several of these factors have had an impact on the continu- 
ing spread of Lyme disease in the United States. Mr. Chairman, I would like to sub- 
mit a copy of the executive summary of the IOM report for your consideration for 
printing as part of the record. 

Lyme disease is an important and preventable public health problem. More than 
9,600 cases of Lyme disease were reported by 45 State health departments to CDC 
in 1992. This figure is a 19-fold annual increase from the 497 cases reported by 11 
states in 1982, the year when CDC began a systematic national surveillance of the 
disease. Nearly 50,000 cases were reported to CDC in the period 1982-1992. 

Lyme disease is a multistage, multisystem disease caused by the spirochetal bac- 
terium, Borrelia burgdorferi. It is a zoonosis, a disease of animals that can be trans- 
mitted to humans. In Lyme disease, the bacterium is transmitted by the bite of cer- 
tain species of ticks. 

The earliest stage of the illness is characterized by fever, flu -like symptoms, and 
the development of a characteristic skin rash, erythema migrans. Although the 
early-stage illness most often responds promptly and well to antibiotic therapy, un- 
treated or inadequately treated Lyme disease can progress to serious conditions, 
such as arthritis, and neurologic and cardiac disorders, that require more intensive 
therapy and may not fully resolve. 

Confirming a case of Lyme disease can be difficult. Signs and symptoms of Lyme 
disease are often diverse and nonspecific, and laboratory tests have demonstrated 
serious limitations in reliability and accuracy. However, laboratory testing meth- 
odologies are now being standardized. 

Although Lyme disease cases have been reported by 48 states, cases are con- 
centrated in the northeastern, north central, and Pacific coastal regions. Ten states 
reported 88 percent of all cases reported nationally from 1982 through 1992. 

The distribution of human Lyme' disease cases in the United States closely cor- 
relates with the distribution of its principal vectors: the deer tick in the north- 
eastern and upper midwestern regions, ana the western black -legged tick in the Pa- 
cific coastal region. The recent increase in numbers of cases of Lyme disease and 
its geographic spread in the United States are related to the apparent spread of the 
deer tick m the eastern United States, and probably results from the great resur- 
gence in deer populations in the region over the past several decades. This resur- 
fence is compounded by the growth of new suburbs, where people move into areas 
ordered by woodlands, favorable environments for deer, deer mice, and other mam- 
mals that are hosts for B. burgdorferi and ticks that transmit the bacteria. 

Avoiding tick habitats and using personal protective measures are the mainstays 
of preventing Lyme disease. Early recognition and removal of attached ticks is espe- 
cially important because it takes approximately 36 hours for the attached tick to 
transmit the bacterium. The transmission cyc'e in residential areas may be suscep- 
tible to control measures such as habitat modification to remove plant growth and 
litter that can harbor ticks and their mammalian hosts, constructing deer enclo- 
sures, and using pesticides targeted to particular hosts as well as applying pes- 
ticides to a wide area. Stopping transmission in residential areas should signifi- 
cantly reduce the numbers of Lyme disease cases. 

The overall objective of prevention and control measures is to reduce the incidence 
of early Lyme disease cases in highly endemic states to no more than 5 cases per 
100,000 people, or less, by the year 2000. Currently, incidence rates in these states 
range from 10 to 53 cases per 100,000. 

CDC, as the Nation's prevention agency, is leading the Nation's efforts to develop 
a comprehensive, science-based, public health program for Lyme disease prevention 



83 

and control, including surveillance; epidemiologic investigations; improving methods 
of diagnosis; ecology, prevention and control; and education programs. CDC has de- 
veloped an intramural and extramural Lyme disease program that addresses each 
of these components. 

The Lyme disease program at CDC has been funded by Congressional appropria- 
tions of approximately $5.5 million annually during the period 1991-1993. Annually 
approximately $3.0 million of these appropriations have been awarded to State and 
local health departments, foundations and organizations, and universities through 
cooperative agreements and contracts to support research and education. CDC 
works in close partnership with these organizations and other Federal agencies, in- 
cluding the National Institutes of Health, the Food and Drug Administration, the 
Department of Defense, and the National Park Service. I would like to describe this 
program in more detail. 

l. National Surveillance of Lyme Disease 

In 1982, CDC began a systematic collection of numbers of cases of Lyme disease 
reported to State health departments. The authority to make a disease notifiable 
rests with the states. State health departments determine which diseases must be 
reported to them by physicians and diagnostic laboratories within their borders and, 
through the Council of State and Territorial Epidemiologists (CSTE), which diseases 
the states will report to CDC. In 1990, CSTE adopted a uniform surveillance case 
definition for Lyme disease and approved a resolution making Lyme disease nation- 
ally reportable beginning in 1991. Forty-nine states and the District of Columbia 
now rehire reporting of Lyme disease. 

The Lyme disease surveillance case definition was developed specifically for public 
health surveillance of cases and not for purposes of clinical diagnosis or determina- 
tion of health insurance or medical disability benefits. The surveillance case defini- 
tion was discussed during a March 1993 meeting of outside consultants, including 
representatives of CSTE, other public health personnel, clinicians, and 
laboratorians. As a result of these and subsequent discussions, CDC recommended 
to CSTE that no changes be made in the current surveillance case definition. No 
changes in the definition were made by CSTE at their annual meeting during the 
week of June 14, 1993. CDC has no current plans to revise the surveillance case 
definition for public health surveillance of Lyme disease. 

Active surveillance has been supported by CDC cooperative agreement funds in 
sue highly endemic states. During 1992, Connecticut (53.6 cases per 100,000), Wis- 
consin (10.7), and California (0.8) reported the highest rates in the northeast, north 
central, and Pacific coastal regions, respectively. Rates in some counties in Califor- 
nia, Connecticut, Massachusetts, New York, and Wisconsin exceeded 200 cases per 
100,000; the incidence was highest in Nantucket County, Massachusetts (449.1). 
The number of reported cases in Connecticut and Rhode Island detected by active 
surveillance increased 48 percent and 93 percent, respectively, over 1991. New York 
reported a provisional total of 3370 confirmed cases during 1992, a decrease of 574 
cases from 1991. From 1991 through 1992, decreases were greatest in Westchester 
(from 1762 cases to 1154 cases) and Suffolk (from 860 cases to 654 cases) counties. 
The decrease in reported cases in Westchester and Suffolk counties, New York, 
probably reflects reductions in State and county surveillance personnel necessary to 
maintain previous levels of case detection and validation. This phenomena empha- 
sizes the need for personnel in local and State health departments dedicated to sur- 
veillance activities and liaisons with physicians. In addition to instituting active 
surveillance in other parts of the country, the development of standardized, sen- 
sitive and specific serologic tests should result in improved estimates of Lyme dis- 
ease. 

CDC works with State and county health agencies and others to map the distribu- 
tion of B. burgdorferi and the ticks that transmit the bacterium. This surveillance 
has documented an expansion of the known geographic area where the bacterium 
is distributed in nature. New vectors and hosts of B. burgdorferi have been identi- 
fied which indicates that the bacterium can adapt to more diverse environments and 
to a wider range of mammalian hosts than was previously believed. In addition, 
birds can transport vector ticks and have been implicated in disseminating the dis- 
ease. 

Surveillance efforts will be continued to improve the accuracy of the estimates of 
incidence and prevalence of Lyme disease in the United States, as well as trends 
in its occurrence and its geographic spread. 



84 

2. Epidemiologic Investigations 

CDC has responded to a number of State health department requests for assist- 
ance with epidemiologic investigations of Lyme disease. Notably, CDC collaborated 
with the New York Health Department to determine that the attack rate for highly 
endemic residential communities in Westchester County was approximately 3.0 per- 
cent over a single Lyme disease transmission season (May-September), and that the 
likelihood of ever having Lyme disease was approximately 17 percent for residents 
of these communities. Companion ecologic studies in these communities identified 
infected ticks on 65 percent of residential properties, and found that approximately 
30 percent of vector ticks were infected with B. burgdorferi. Studies in New York 
and in Pennsylvania have identified a number of personal behaviors and property 
characteristics that are related to an increased risk of Lyme disease. Results of 
these studies can be directly applied to educational efforts on prevention. 

Studies in New Jersey of school children who required home tutoring because they 
were receiving prolonged treatment for suspected Lyme disease with intravenous 
antibiotics highlighted the great social and economic impact that Lyme disease can 
have on patients and their families and identified the potential for serious adverse 
consequences of intravenous antibiotic treatment. Follow-up studies in patients hos- 
pitalized for treatment of suspected Lyme disease in New Jersey documented these 
risks and suggested measures for their prevention. 

Studies in Missouri of suspected Lyme disease patients identified an illness ac- 
companied by a tick-associated rash that is similar to Lyme disease but without 
clear evidence of infection with B. burgdorferi or other known infectious agents. Fur- 
ther studies to determine the cause of this illness are in progress. 

Studies are in progress to further characterize the epidemiologic features of Lyme 
disease, to determine better the factors associated with risk of infection and disease, 
and to measure better the public health impact of Lyme disease, including the eco- 
nomic and social costs. Populations at high risk need to be studied to determine the 
costs and benefits of various intervention strategies, including the use of future vac- 
cines and efforts directed at the control of tick vectors. Guidelines are needed on 
the proper use and interpretation of laboratory diagnostic methods, clinical diag- 
nosis, and the most appropriate ways to treat Lyme disease in its various stages. 

3. Development of Improved Diagnostic Laboratory Tests 

Important progress has been made in improving diagnostic laboratory tests for 
Lyme disease. Studies in New York and Wisconsin supported by CDC contracts and 
cooperative agreements have shown that it is possible to isolate B. burgdorferi from 
the skin of 70 percent of patients with the rash of early Lyme disease. Serum speci- 
mens collected from patients in this study and from other studies in states with 
CDC cooperative agreements (Connecticut, Massachusetts, New Jersey, New York, 
and Wisconsin), as well as serum from other clinically characterized and laboratory 
confirmed patients throughout the United States, have served as a reference panel 
for development, evaluation, and standardization of tests detecting antibodies to B. 
burgdorferi. 

Collaboration with the Association of State and Territorial Public Health Labora- 
tory Directors (ASTPHLD) and the Food and Drug Administration (FDA) has led 
to the distribution of serum panels to more than 50 manufacturers and other re- 
searchers and to the development of guidelines leading to clearance of candidate test 
methods by FDA. CDC and ASTPHLD have developed a standardized approach to 
testing that is highly reliable with improved specificity and sensitivity for detection 
of antibodies to a. burgdorferi. A workshop co-sponsored by CDC and ASTPHLD was 
held on this standardized approach in March. In addition a pilot program to evalu- 
ate this approach has begun in selected State public health laboratories across the 
country. 

Progress is being made by CDC and its collaborators in identifying molecular 
subcomponents of B. burgdorferi that have the potential for use in a new generation 
of highly sensitive and specific laboratory tests for Lyme disease. An animal model 
of Lyme disease developed by Tulane University, in collaboration with CDC, pro- 
vides opportunities for evaluating new test methods in various stages of infection 
and disease before and after treatment. 

Development of national guidelines, in collaboration with Nffl, FDA, other Fed- 
eral agencies, and State and local health departments, on the use and interpretation 
of standardized Lyme disease laboratory tests is anticipated. 



85 

4. Ecology, Prevention, and Control of Lyme Disease 

The prevention of Lyme disease is based on personal protection and environ- 
mental and ecological strategies to reduce exposure to ticks infected with B. 
burgdorferi. In some communities where the disease is endemic, the risk of exposure 
is present in routine daily activities and personal protective measures may be insuf- 
ficient. In such circumstances, all of the following strategies may be necessary: the 
use of chemical pesticides, habitat modification, and management of the animals 
that serve as hosts for the ticks carrying the bacterium. 

Studies conducted by the New York Medical College and the New Jersey State 
Department of Health have shown that properly timed single applications of com- 
monly used EPA registered pesticides can reduce populations of nymphal vector 
ticks (the stage responsible for most transmission of disease to humans) by 90 per- 
cent or more on residential properties for a whole transmission season. Strategies 
that target particular hosts, such as using chemicals to control ticks on rodents and 
deer, are under evaluation. A promising new environmentally sound approach is to 
use baited tubes for the control of ticks on mice and other rodent reservoirs of B. 
burgdorferi. Animals that crawl into these tubes to reach the bait pick up livid 
permethrin dust, a safe and long-lasting residual pesticide. Other innovative strate- 
gies are being developed to kill ticks on deer and to exclude deer from residential 
properties. 

CDC funded collaborative studies of the ecology of Lyme disease have documented 
a much wider range of habitat and mammalian hosts that maintain B. burgdorferi 
and vector ticks than previously recognized. The Norway rat was found to be the 
principal reservoir host of B. burgdorferi on an island off the coast of Maine; cotton 
rats and cotton mice serve as reservoir hosts in Georgia and Florida; chipmunks 
may serve as principal hosts in some habitats in the north-central states; and the 
wood rat serves as principal reservoir host in the western region of the United 
States. Recent studies in Colorado and California have identified a previously unrec- 
ognized tick vector, Ixodes spinipalpis, that transmits B. burgdorferi between ro- 
dents. r 

There are no currently recognized means of limiting the geographic spread of 
Lyme disease in the United States. The disease is now established in nature in at 
least 20 states. Although the disease appears to spread slowly to neighboring areas 
due to dissemination ofticks by deer, carnivores, and other medium-sized mammals, 
it is possible that birds play a secondary role in dissemination, both by transporting 
ticks along migratory pathways as wefi as by serving as reservoirs of infection of 
B. burgdorferi. Studies of this and other potential factors of emergence are in 
progress. 

s. Lee Disease Education 

Public education is a high priority in the CDC Lyme disease program. More than 
25 percent of the program's nearly $3 million in cooperative agreement funds are 
spent annually for education on Lyme disease. Cooperative agreement projects with 
State and local health departments, universities, and private nonprofit foundations 
are now in the third year of funding. The types of educational materials produced 
include classroom modules using video and written materials, computer interactive 
programs, public service announcements for radio and television, brochures, post- 
ers', and videos for public service transmission. The audiences targeted by these ma- 
terials range from young children to adults. With few exceptions, these materials 
are available without charge. CDC has collaborated with cooperative agreement re- 
cipients to distribute videotaped materials to all primary and secondary schools in 
targeted counties of states where Lyme disease is most highly endemic. 

CDC will continue to base the national program for the prevention and control 
of Lyme disease on partnerships with State and local health departments, NIH, 
FDA and other Federal agencies; private, professional and voluntary foundations 
and organizations; and universities. Goals include developing comprehensive 1 
science-based, intramural and extramural public health programs. These programs 
include: 1) improving national surveillance for determining accurate estimates of in- 
cidence and for monitoring the geographic spread of the disease; 2) identifying popu- 
lations at high risk and identifying behavioral and environmental risk factors ame- 
nable to reduction strategies; 3) improving laboratory tests for clinical and epidemio- 
logic purposes; 4) developing methods of personal protection; 5) outlining strategies 
to reduce exposure to infective ticks; 6) educating the public and health care com- 
munities on relevant aspects of the disease' and its prevention; and 7) determining 
Sublic health impact by measuring morbidity and social and economic costs of this 
isease. 



73-299 - 93 - 4 



86 

In conclusion, our experience with Lyme disease illustrates important lessons. As 
documented in the IOM report on emerging infections, we can expect new infectious 
diseases to continue to emerge and spread in the United States as a result of micro- 
bial evolution and technological change. Conditions with unknown etiologies can 
turn out to have an infectious cause. The challenges posed by Lyme disease high- 
light the need for improved surveillance, epidemiologic assessment of new or un- 
usual diseases, and networks of State and national public health agencies and lab- 
oratories, as recommended in the Institute of Medicine report, to detect the emer- 
gence of pathogens. Prevention also requires close multiagency collaboration, espe- 
cially for diseases with potentially devastating consequences and the ability to 
spread rapidly. 

Thank you for the opportunity to discuss CDCs role in the prevention and control 
of Lyme disease. Dr. Gubler and I will be pleased to answer questions you or mem- 
bers of the committee have. 

Responses of Dr. McDade to Questions Asked by Senators Dodd and 

Metzenbaum 

Question. Senator Metzenbaum was concerned that physicians be notified of cur- 
rent information on Lyme Disease to raise their level of awareness. He indicated 
he thought there was a gap between what is known and what occurs in the field. 
What are CDCs activities geared toward educating physicians about Lyme Disease? 

Answer. CDC has published a Lyme disease informational brochure and publishes 
the weekly Morbidity and Mortality Weekly Report (MMWR) featuring timely dis- 
ease specific information for health care providers. A copy of the brochure and re- 
cent copies of the MMWR highlighting Lyme disease are included. CDC also main- 
tains a telephone Voice Information system [(404) 332-45650] providing health care 
professionals and the public with information on specific diseases. This system is 
organized so that direct telephone contact with CDC's Lyme disease program staff 
is available. Information concerning access to this system is published in the 
MMWR. 

Education is the key to the prevention of Lyme disease and its early detection and 
appropriate treatment. Congress directed that 25 percent of appropriated funds for 
cooperative agreement research be applied to national education efforts for health 
care providers and for the public. Educational project awards were made by CDC 
to the New York and Connecticut State Health Departments, to Pennsylvania State 
University, and to four private, nonprofit organizations (Lyme Borrehosis Founda- 
tion, Marshfield Clinic, American Lyme Foundation, and the Arthritis Foundation, 
Connecticut Chapter). 

Listed below is a synopsis of cooperative agreement projects providing education 
and information through this extramural program. 

The Marshfield Clinic (Wisconsin) has produced educational materials for health 
care providers, a video-taped educational program for school children, brochures for 
the general public, and a teacher's manual. 

The American Lyme Foundation (New York) has established a telephone informa- 
tion hot-line service and has produced educational videos. Public service announce- 
ments have also been produced. Written material is available for the lay public, and 
an informational brochure for physicians and other health care workers is being pro- 
duced. 

Pennsylvania State University has conducted two national caller-interactive Lyme 
disease television presentations, dealing with the basic biology, diagnosis, treat- 
ment, prevention, and control of Lyme disease. An information service nas been de- 
veloped on the distribution of the tick vector of Lyme disease in Pennsylvania, and 
a glossary of approximately 1,000 Lyme disease terms has been constructed. Videos 
and written materials for school children, adults, and medical professionals have 
also been developed. Public service announcements on Lyme disease prevention are 
distributed prior to the Lyme disease transmission season. 

The New York State Health Department is working with Westchester and other 
country health departments to produce brochures, videos, public service announce- 
ments, and has developed a system of user-interactive computer kiosks on Lyme dis- 
ease that provide evaluations of information transfer to users. Many of these mate- 
rials are available and in use. 

The Lyme Borreliosis Foundation has developed and is distributing instructional 
videos aimed at school children, the general public, and workers at risk because of 
occupational exposures. Videos for school children based on the Muppets have been 
shown at the 6th International Conference on Lyme Borreliosis and the annual 
meeting of the American Public Health Association. These educational materials 
also serve Spanish-speaking and hearing-impaired audiences. Several public service 



87 

announcements have been produced and widely shown and aired through the re- 
gional media. A wide range of written materials has also been produced and distrib- 
uted. 

The cooperative agreement projects listed below include specific educational ap- 
proaches that have been developed for other targeted audiences. 

The Connecticut State Health Department has developed a Lyme disease edu- 
cation module for 9th grade students that includes a video, and is completing a 
similar product for 4—6th grade students. Connecticut is participating with CDC in 
a national Lyme disease behavioral risk factor survey. 

The Arthritis Foundation (Connecticut Chapter) has produced bilingual posters 
and brochures, and is completing development of an interactive computer video pro- 
gram to educate elementary school children. CDC professional staff also participate 
in appropriate medical and scientific meetings to educate health care professionals 
and others. 

Question. Senator Dodd asked that Dr. McDade submit for the record his profes- 
sional judgment recommendation for CDC's Lyme Disease funding needs and how 
those funds would be spent. 

Answer. Dr. McDade's professional judgment budget estimate for a Lyme disease 
prevention program level is $6.4 million. In working toward the goal of prevention 
of Lyme disease, specific activities of CDC would include: 

Initiating cooperative agreements with State and local health departments to im- 
prove and standardize active surveillance, and conduct epidemiologic and ecologic 
studies that better define factors of risk, and enhancement of national surveillance 
activities to achieve more rapdily uniform surveillance practices by States, to mon- 
itor better and analyze trends of disease distribution and frequency. 

Promoting increased assistance to State and local health departments and other 
institutions to conduct environmental and ecologic studies that define factors in the 
enzootic cycle related to disease distribution and risk, and supporting pilot studies 
of integrated pest management for interrupting the chain of transmission. 

Promoting increased laboratory research to develop and evaluate improved diag- 
nostic methodologies, strengthening national reference capabilities, and establishing 
standards and guidelines for diagnostic testing; providing support to selected State 
public health laboratories to develop and evaluate models of standardized serologic 
testing and quality assurance; and conducting training of public health laboratory 
personnel in standardized testing and quality assurance. 

Developing and distributing educational materials targeted for physicians on diag- 
nosis, treatment and prevention, and developing and distributing educational mate- 
rials specifically aimed at community and school use that provide information on 
risk avoidance, personal protection, and early disease detection, as well as preven- 
tion strategies for environmental management. 

Initiating cooperative agreements with State and local health departments to im- 
plement and evaluate prevention and control programs. 

Initiating cooperative agreements with State and local health departments and 
other institutions to quantify the public health burden of Lyme disease in early and 
late stages, including measures of morbidity and cost. 

Senator Dodd. Dr. LaMontagne. 

Mr. LaMontagne. Thank you, Mr. Chairman and members of 
the committee, for inviting me to appear before you to discuss ongo- 
ing and planned Lyme disease research activities of the National 
Institute of Allergy and Infectious Diseases, a component of the 
NIH. 

Research advances in microbiology made during the 20th century 
really make life in modern society possible. Smallpox has been 
eradicated from the globe, and in the United States, infectious dis- 
eases such as polio, whooping cough, measles, typhoid, diphtheria 
and many others that were once major killers in this country are 
now uncommon. 

This backdrop of tremendous accomplishment has supported the 
perception that infectious diseases are one problem that we have 
solved. Unfortunately, the recent emergence of new infectious dis- 
eases such as Lyme disease provides ample evidence that this per- 
ception is incorrect. 



88 

Moreover, the history of the 20th century tell us that despite the 
many advances we have made in the diagnosis, prevention, and 
treatment of infectious diseases, we continue to be vulnerable to ei- 
ther truly new infectious diseases or to old infectious diseases 
reemerging into a newfound prominence. 

Lyme disease is only one example of this kind of problem. It is 
a newly recognized infectious disease that is also emerging. The 
NIH has supported research on Lyme disease since the first cluster 
of cases was studied by Dr. Allen Steere, whom you heard from in 
the earlier panel of witnesses, from his studies in Old Lyme, CT 
more than 15 years ago. 

The causative agent for Lyme disease, B. burgdorferi, was iso- 
lated and identified at NIAID's Rocky Mountain Laboratories in 
Hamilton, MT. The NIAID has supported Lyme disease research at 
the Rocky Mountain Laboratories ever since. 

In addition, NIAID has supported Lyme disease research in the 
extramural community since 1985. Other components of the NIH. 
such as the National Institute of Arthritis and Musculoskeletal and 
Skin Diseases, and the Neurology Institute, have also joined the re- 
search effort to understand Lyme disease by supporting many im- 
portant research projects. 

Lyme disease is now the most commonly reported arthropod- 
borne disease in the United States. It is certainly the most common 
tick-borne infection in the United States. The disease, caused by 
the spirochete B. burgdorferi, is transmitted primarily by the ticks 
of the genus Ixodes. Lyme disease may be acute or self-limited, or 
may develop into a chronic multisystem disease that can elicit a 
wide and unpredictable range of clinical manifestations. 

Current diagnostic tests, which are based on the detection of 
antibodies to B. burgdorferi, are useful but far from perfect, since 
individuals may vary in their immunologic response to infection, 
thus limiting the value of blood test results in the diagnostic proc- 
ess. 

Senator Metzenbaum. (Presiding]. Doctor, I want to ask you if 
you would, please — I want to hear what you have to say, and I 
want to get the thrust of it and we will read your full statement. 
But because of the press of time that I and obviously other mem- 
bers of the committee have, I want to be courteous to you because 
I think you have something to say. I am wondering if we could get 
you to just talk to us and tell us where you are and what you are 
doing. 

(The prepared statement of Mr. LaMontagne follows:] 

Prepared Statement op John LaMontagne 

Thank you, Mr. Chairman and Members of the Committee, for inviting me to ap- 
pear before you to discuss ongoing and planned Lyme disease research activities of 
the National Institute of Allergy and Infectious Diseases (NIAID), a component of 
the National Institutes of Health (NIH). My name is John La Montagne and I am 
the Director of the Division of Microbiology and Infectious Diseases, an NIAID ex- 
tramural research division. I also serve as the Chair of the NIH Lyme Disease Co- 
ordinating Committee. 

Research advances in microbiology made during the twentieth century make life 
in modern society possible. Smallpox has been eradicated from the globe and in the 
United States, Infectious diseases such as polio, whooping cough, measles, typhoid 
fever and diphtheria, once major killers in this country, are now uncommon. In ad- 
dition, we are now able to predict with some certainty the year to year changes in 
the Influenza virus and design a protective flu vaccine. 



89 

This backdrop of tremendous accomplishment has supported the perception that 
infectious diseases are one problem that we have solved. Unfortunately, the recent 
emergence of new infectious diseases, such as Lyme disease, provides ample evi- 
dence that this perception is incorrect. Moreover, the history of the 20th century 
tells us that, despite the many advances we have made In the diagnosis, prevention, 
and treatment of infectious diseases, we continue to be vulnerable to either truly 
new infectious diseases or to old infectious diseases re-emerging into a new found 
prominence. 

Lyme disease is only one example of this kind of problem. It is a newly recognized 
Infectious disease that is also emerging. The NIAID has supported research on 
Lyme disease from the first reports of cases in the early 1980s. The etiologic agent 
for Lyme disease, Borrelia burgdorferi, was isolated and identified at the NIAlD's 
Rocky Mountain Laboratories (RML) by researchers Willy Burgdorfer and Alan 
Barbour while working with New York State Health Department researchers Jorge 
Benach and Edward Bosler in 1981. The NIAID has supported Lyme disease re- 
search at the RML ever since. In addition, NIAID has supported Lyme disease re- 
search in the extramural community since 1985. Other research components of the 
NIH, such as the National Institute of Arthritis and Musculoskeletal and Skin Dis- 
eases (NIAMS) and, more recently, the National Institute of Neurological Disorders 
and Stroke (NINDS), also support Lyme disease research. 

Lyme disease is now thought to be the most commonly reported arthropod-borne 
disease in the United States — it is certainly the most common tick-borne infection 
in the United States. The disease, caused by the spirochete B. burgdorferi, is trans- 
mitted primarily by ticks of the genus Ixodes. Lyme disease may be acute or self- 
limited or may develop into a chronic multisystem disease that can elicit a wide and 
unpredictable range of clinical manifestations. Current diagnostic tests, which are 
based on the detection of antibodies to B. burgdorferi, are useful, but far from per- 
fect since individuals may vary widely in their immunological response to infection, 
thus limiting the value of blood test results In the diagnostic process. 

As indicated, Lyme disease does not have a predictable clinical presentation or 
progression of symptoms. Most persons infected with B. burgdorferi respond to infec- 
tion with strong immune responses, whereas others show no sign of infection in 
their blood. The organism also is very difficult and in some cases impossible to de- 
tect in infected individuals. Many published descriptions indicate that the hallmark 
of Lyme disease is an expanding red rash, known as erythema migrans, that may 
be accompanied by various other clinical signs and symptoms. Infected individuals 
actually present a highly variable array of signs and symptoms, such as joint pain 
and nerve problems, that may be easily confused with those of other diseases. The 
ambiguities inherent in interpreting the results of blood tests for Lyme disease 
added to these nonspecific symptoms have led to problems with both over- and 
under-di agnosia of the disease. 

NIAID currently conducts and supports several projects aimed at meeting the 
challenges of Lyme disease. Institute goals for this area of research include: 

Improve our understanding of the immune response of infected individuals to B. 
burgdorferi. 

Improve our understanding of the biology and surface variation of B. burgdorferi. 

Develop tissue culture models of Lyme disease. 

Develop animal models of Lyme disease. 

Identify and characterize virulence factors and antigenic determinants of B. 
burgdorferi. 

Develop improved diagnostic and therapeutic strategies. 

Develop an effective human vaccine. 

Study the host range of B. burgdorferi in potential vector (transmitter) and res- 
ervoir (carrier) species. 

Study the biology and ecology of vector and reservoir species. 

Develop strategies for the control of Lyme disease transmission among reservoir 
species and to humans. 

I would like to take this opportunity to highlight for you recent advances made 
in our intramural and extramural programs and to briefly outline our research 
plans for the near future. 

NIAID Intramural Research Program 

INTRAMURAL RESEARCH ADVANCES 

Several NIAID scientists conduct Lyme disease research studies at the RML. 
Highlights of some of their recent efforts are summarized below. 



90 

Scientists at RML have developed a highly sensitive and specific method to detect 
B. burgdorferi infection. Hie assay works well with samples of urine, cerebrospinal 
fluid, blood, and synovial Quid. Because the assay detects components of the infect- 
ing spirochetes rawer than immune responses to it, if it can be developed commer- 
cially, the assay may prove useful for monitoring treatment effectiveness as well. 

A major stumbling block to developing diagnostic tests or a vaccine for Lyme dis- 
ease is the elusive nature of the spirochete. The organism appears to evade the im- 
mune system of the host by changing its surface proteins. NIAID scientists are 
studying changes in genes encoding two major outer membrane proteins of the spi- 
rochete. The studies may provide insights into the surface proteins of not only B. 
burgdorferi but also other borrelia organisms as well. 

MAID'S researchers have genetically characterized samples of Lyme disease bac- 
teria taken from many patients in Europe, Asia, and North America. Based on ge- 
netic relatedness, the scientists have identified at least three distinct groups of 
borreliae that can cause Lyme disease. The frequency with which different Lyme 
disease symptoms occurs is known to vary in different geographic areas. The sci- 
entists have begun examining how the genetic distinctions within each group relate 
to clinical features of Lyme disease. 

NIAID research recently showed that antibodies to a specific protein of the spiro- 
chete, p39, are produced only in response to an active B. burgdorferi infection and 
therefore can serve as reliable markers for Lyme disease. Using this observation, 
the researchers have developed three p39-based blood test kits that can help distin- 
guish patients with Lyme disease from those with other disorders. These kits have 
been approved by the Food and Drug Administration and are currently available to 
doctors, clinics, and hospitals nationwide. 

Scientists at the RML have demonstrated a characteristic of B. burgdorferi that 
may explain its ability to cluster in low numbers at the site of infection and yet 
cause a variety of reactions at other sites in the body. B. burgdorferi cells release 
pouches or "blebs" from their surface that become distributed widely throughout the 
body, unleashing a variety of immune system and tissue responses that may result 
in the diverse symptoms seen in Lyme disease patients. 

Coumermycin Al is an antibiotic that inhibits the enzyme that catalyzes the 
coiling of DNA molecules and is required for bacterial replication and growth. Since 
the Lyme disease spirochete has coiled molecules, NIAID investigators tested the ac- 
tivity of this antibiotic on B. burgdorferi. They found the Lyme disease spirochete 
to be 100 times more sensitive than other bacteria to this compound Although 
coumermycin Al or similar drugs are not ready to be tested in humans, this re- 
search indicates that such drugs should be investigated and developed further as 
potential therapies for human Lyme disease. 

FUTURE PLANS 

The following future plans will be emphasized by NIAID intramural scientists: 

Improve the sensitivity of the blood test kits and other available diagnostic tools. 

Continue studies of the variation and biological effect of Borrelial surface proteins 
with the goal of developing an effective vaccine. 

Examine the attachment and penetration of spirochetes into human cells as a pos- 
sible mechanism of maintaining chronic infection. 

Examine the role of ticks in the maintenance and delivery of the pathogen. 

NIAID Extramural Research Program 

EXTRAMURAL RESEARCH ADVANCES 

Efforts currently funded through this program represent a wide range of research 
related to the study of Lyme disease. Currently, NIAID supports approximately 30 
grants. 

In cooperation with the MAMS, the MAID supported a State-of-the-Art Work- 
shop on the Diagnosis and Treatment of Lyme Disease in March 1991. A publication 
of a newsletter on the same topic was developed following the workshop and has 
been distributed to 65,000 physicians to date. The newsletter aids physicians and 
other health professionals in managing patients that may have contracted Lyme dis- 
ease. 

MAID-supported investigators at Harvard University have reported that immuni- 
zation of mice against a borrelial protein (OspA) confers resistance against infection, 
in part, due to inhibition of transmission of B. burgdorferi from feeding ticks. This 
observation has been confirmed by researchers at the RML and the Centers for Dis- 
ease Control and Prevention (CDC). These results indicate that development of an 
effective vaccine is a realistic objective that should be considered a high priority. 



91 

Further results of the aforementioned study also strongly indicate that antibody 
ingested by infected ticks feeding upon OspA-immunized animals can kill the Lyme 
disease spirochete in the tick gut and actually clear the tick of infection as well. 
This study was conducted in collaboration with grantees at Yale University. 

In studies with mice, Harvard researchers have found that doxycycline (in DMSO) 
may prevent B. burgdorferi infection if the antibiotic is applied topically to the site 
of tick attachment within 4 days after the tick has fallen off. These studies, al- 
though so far only conducted in mice, provide a rationale for pursuing the feasibility 
of testing this approach in humans. 

Two NIAID-supported investigators have independently demonstrated that 
borrelial outer surface proteins can undergo rearrangement, allowing a small per- 
centage of infecting organisms to escape a protective Immune response by the host. 
This observation has important implications for vaccine development. 

Another extramural scientist has developed a rabbit model that is the first animal 
model to exhibit the akin rash often observed in human Lyme disease. This model 
may be useful for improving our understanding of the early events in the infectious 
process of Lyme disease. 

An NIAMS grantee has developed a combined approach using ELISA assays and 
Western blots which can determine with a high degree of sensitivity and specificity 
whether an individual has been exposed to B. Durgdorferi. This advance will be par- 
ticularly useful in providing a standard against which new diagnostic tests for Lyme 
disease can be compared. 

FUTURE PLANS 

The following research areas will continue to be emphasized in the NIAID extra- 
mural research program: 

BIOLOGY OF BORRELIA BURGDORFERI 

Develop a defined culture medium for growing the bacterium. 
Characterize the physiology of the organism and genetically identify Its surface 
structures. 
Compare 8. burgdorteri with closely related bacteria causing relapsing fever. 

ECOLOGY OF LYME DISEASE 

Study potential and established vectors and reservoirs. 

Define the role of ticks and other vectors in sustaining virulence. 

Support international efforts to study strain variations. 

IMMUNITY AND VACCINES 

Define how different immune mechanisms influence resistance or susceptibility to 
infection. 
Study the roles of the various types of immune responses in infected individuals. 
Develop better animal models. 
Assist in supporting trials of Lyme disease vaccines for humans. 

\ 
DIAGNOSIS 

Improve the sensitivity and specificity of diagnostic blood tests. 
Refine polymerase chain reaction techniques to detect B. burgdorferi. 
Develop standardized reagents for use in evaluating diagnostics. 
Improve the ability to discriminate cases of chronic Lyme disease from similar 
symptoms due to other etiologies. 

TREATMENT 

Determine the most appropriate dosages and time courses necessary to 
leffectively treat the different manifestations of Lyme disease. 
Evaluate new treatment regimens for Lyme disease. — *» 

CONCLUSION 

In conclusion, NIAID is firmly committed to supporting the scientific research 
that is an essential component of any successful strategy to address Lyme disease. 

Although we cannot anticipate every emerging disease, nor forecast all public 
health emergencies, we can be prepared to meet the challenges posed by new and 
re-emerging diseases by maintaining our strong basic biomedical research infra- 



92 

structure. By doing so, we are able to move ahead as expeditiously as possible to 
develop vaccines and improve diagnostics and treatments. 

This concludes my prepared statement, Mr. Chairman. I will be pleased to answer 
any questions you and the members of the committee may have. 

Mr. LaMontagne. That will be perfectly fine, Senator. 

I think the thrust of our activities at the NIH has been basically 
to improve diagnostic methods. We have felt that that was our first 
priority if in met we were going to pursue a strategy to improve 
approaches to prevent the disease. I think prevention is the goal 
that all of the panelists that you have heard from today would 
want to achieve, and prevention, of course, takes many steps. It 
can be prevention by vaccination, prevention by education, preven- 
tion by control 

Senator Metzenbaum. Do you think the diagnostic means that 
are presently available are not accurate? 

Mr. LaMontagne. It is a rapidly evolving field, Senator. The di- 
agnostic test that is generally commercially available is useful, but 
not perfect, by a long shot. Inhere are new tests that have been de- 
veloped, such as using the technique called PCR, and other tech- 
niques which actually detect parts of the organism in specimens 
from patients, that may be much more useful in diagnosis. How- 
ever, they are available only in very scarce locations at the mo- 
ment. 

Senator Metzenbaum. How does the doctor in Wapakoneta, OH, 
a very tiny community, learn about these procedures, and how do 
his patients get treated? What I am trying to do is just on a prac- 
tical level, not on a textbook level. 

Mr. LaMontagne. We understand. Senator, and that is a con- 
cern that we have in fact tried to address. In fact, 2 years ago, we 
convened a meeting at the NIH on the diagnosis and treatment of 
Lyme disease which resulted in a publication which we distributed 
to 65,000 physicians throughout the United States. So we have 
tried to get more immediate kinds of information to physicians. 
That document did deal with some of the diagnostic dilemmas asso- 
ciated with Lyme disease and also talked about some of the newer 
techniques. 

Senator Metzenbaum. What should I do if a woman from 
Wapakoneta, OH calls me and asks, "What do I do? I don't think 
the doctors out here know much about this. Where do I turn? I am 
concerned that this may be Lyme disease, and I am also aware of 
the fact that there are many misdiagnoses in this field." She wants 
to know what she should do. What would I tell her? 

Mr. LaMontagne. Senator, there are several things that one can 
do in that situation. You can notify us; the Lyme Borrelia Founda- 
tion as well has the ability to refer patients to physicians, and we 
would be glad to identify someone in the State of Ohio or anywhere 
near that person that we think might be a useful place for that pa- 
tient to be seen. 

We have done that in the past, and presumably would continue 
to do so. 

Senator Metzenbaum. On a scale of one to 10, how do you think 
the physicians in this country are handling a) the question of diag- 
nosis and b) the question of treatment, appropriately? 

Mr. LaMontagne. Well, I think Dr. McDade stated that in a way 
that I would as well, Senator. I think there is a lot more that we 



93 

can do to try to educate physicians, and not just physicians, but 
nurses and other health care professionals, in identifying and chan- 
neling these patients into the appropriate places for care. 

Senator Metzenbaum. How can we help you? 

Mr. LaMontagne. Well, I think this hearing is helping in a way. 

Senator Metzenbaum. I'm not satisfied. I think this is a good 
first step. But I have the feeling that these people who are sitting 
behind you and who are so concerned about this illness are pleased 
that there is a hearing convened by this committee and Senator 
Kennedv, but I think that I for one feel that we have touched upon 
the problem, we have discussed the problem, but we haven't done 
enough about providing the solution. And the solution in part has 
to do with the education of physicians, better means of testing — 
one doctor says that the tests that are available now are good tests, 
the other doctor says they aren't. You are part of our Government 
in this particular area, and I am just trying to find out what we 
can do more than what we are presently doing, or what we can ask 
you to do more than you are presently doing. I as a Senator cannot 
do anything. 

Mr. LaMontagne. Well, Senator, that's obviously a complex 
question. Let me say that a lot has been done in terms of the diag- 
nosis of Lyme disease and improving those tests. There is a good 
bit of effort on the part of investigators that we support, working 
at the Rocky Mountain Laboratories, and we now support over 50 
laboratories in the United States doing research on Lyme disease. 
So there is a good deal of energy in that group that has partnered, 
if you will, with the efforts of the CDC to better define Lyme dis- 
ease diagnostic tests. And I predict that within the next year or so, 
that investment will begin to pay off with better approaches. 

So my answer to you is I think I would defer until those kinds 
of results are in, before commenting further. 

Senator Metzenbaum. Can you accelerate the pace a little bit? 
I'm only going to be here 17 months, and I want to see you get 
something done before I leave here. [Laughter.] 

Dr. McDade and Mr. LaMontagne, unless either of you have 
something further that you want to put in the record, both of your 
statements will be included in the record in full, and the record ac- 
tually will remain open for a period of 1 week for any further state- 
ments that are to be included. 

We are very grateful to you, and I think the message that we'd 
like to have you take away from here is that we want some results; 
we want more action than presently has occurred. We support your 
efforts. We are talking about absolute pittances of dollars as far as 
money in this town is concerned — it's an absolutely negligible 
amount of money. So if you need something more, I am saying to 
you as strongly as I can: Tell us what it is. That doesn't mean I 
want you to tell us how to waste money, but I want you to tell us 
how much more you need and what you would do with it and why 
it would help solve this problem that concerns so many Americans. 

If you have nothing further, there are no other members present, 
and I would thank you very much for your cooperation, and I thank 
those who are in the room who are concerned about this problem. 

This meeting stands adjourned. 



94 

[Editor's note — The committee has received numerous letters and 
articles on Lyme disease. Because of the volume and cost, it is fea- 
sible for the committee to print only the official hearing and testi- 
mony presented at that time. However, all the letters and articles 
are retained in the committee files.] 

[A listing of people and/or organizations who submitted testi- 
mony and articles follows:] 



95 



LYME DISEASE HEARING LOG 8/5/93 



LYME DISEASE FOUNDATION TESTIMONY 



SUZANNE M. SMITH 



TESTIMONY 



1 FINANCIAL PLAZA 
HARTFORD, CT 06103 

P.O.BOX 488 

LITTLE RIVER, CA 95456 



NANCY A. BROWN 



REP. GEORGE HOCHBRUECKNER TESTIMONY 



DANIEL W. RAHN, M.D 



ARTHUR H. ACKERMAN 



TESTIMONY P.O. BOX 26 

WEAVERVILLE, CA 96093 

229 CANNON HOB 
WASH., DC 20515-3201 

STATEMENT MEDICAL COLLEGE OF GA 
AUGUSTA, GA 30912 

TESTIMONY 113 WASHINGTON VALLEY RD 
MORRISTOWNSHIP, NJ 07961 



WESTCHESTER CTY MED CNTR STATEMENT 



NEW YORK MEDICAL 
Valhalla, NY 10595 



ANDREW R. PACHNER, M.D. STATEMENT 



NIAMS COALITION 



5 STATEMENTS 



GEORGETOWN UNIV. MED. CNT 
DEPT. OF NEUROLOGY 
3800 RESERVOIR ROAD NW 
WASH., DC 20007-2197 

LYME BORRELIOSIS FOUNDATI 

BOX 4 62 

TOLLAND, CT 06084-0462 



HIP RUTGERS HEALTH PLAN 



CORPORATE OFFICE 

1 WORLDS FAIR DRIVE 

SOMERSET, NJ 08873 



MARC C. GABRIEL 



STATEMENT 1050 LAWRENCE AVENUE 

WESTFIELD, NJ 07090-3721 



BARRY N. FINCH 



STATEMENT 80 CANTERBURY LANE 

RIDGEFIELD, CT 06877 



ELAINE YARYAN 



HEARING PKG 



38630 TRAFALGAR WAY 
STERLING HIGHTS, MI 48312 



MS. JULIA BOLDT 



STATEMENT 



68 MAINE AVENUE 
WHITING, NJ 08759 



ADR1ENNE MALIS 



BARRY FINCH 



STATEMENT 3300 N.E.192 ST. 11018 

ANEATURA, FLORIDA 33180 

STATEMENT 80 CANTERBURY LN 

RIDGEFIELD, CT 06877 



JONATHAN LITTLE 



DEBRA BRENSINGER 



LETTER 



LETTER 



LITTLE WORKS STUDIO 

RTE 2, BOX 23 

GLADSTONE, VA 24553-9203 

101 WILLOW AVE 
PISCATAWAY, NJ 08854 



96 



DOLORES B I CHARD 

JOHN B I CHARD 

RICHARD TEGNANDER 

GLORIA WENK 

KAREN FORSCHNER 
CARL BRENNER 

AMY M. CURRIER 
KEITH BURCH, M.D. 



MARC I A JOHNSON, M.D, 



TIMOTHY LAING, M.D. 



EVA FELDMAN, M.D. 



LETTER 



LETTER 



LETTER 



LETTER 



TESTIMONY 

TESTIMONY 
11 COPIES 



HEARING 



HEARING 



HEARING 



HEARING 



HEARING 



1242 CATHCART BLVD 
SARNIA, ONTARIO N7S 2H6 

124 2 CATHCART BLVD 
SARNIA, ONTARIO CANADA 

59 SOBRO AVENUE 

VALLEY STREAM, N.Y. 11580 

40 GUERNSEY HILL RD 
LAGRANGEVILLE, NY 12540 

NO ADDRESS 

LYME TREATMENT NEWS 
17 MONROE AVENUE 
STATEN ISLAND, 10301 

P.O. BOX 1030 

DEARBORN HEIGHTS, MI 48127 

INTERNAL MEDICINE 

HENRY FORD MEDICAL CENTER 

WEST BLOOMFIELD 

677 7 WEST MAPLE ROAD 

WEST BLOOMFIELD, MI 48322 

29255 SOUTHFIELD 

SUITE 102 

SOUTHFIELD, MI 48034 

TAUBMAN CENTER 3918-0358 
1500 E. MEDICAL CNTR DR. 
ANN ARBOR, MI 48109-0358 

TAUBMAN CENTER 1324-0322 
1500 MEDICAL CENTER DR. 
ANN ARBOR, MI 48109-0322 



STANLEY MILLER, M.D. 



DOCTOR RIZVI 



MR. BILL LAITNER 



MR. S MRS. HAMILTON 



DOROTHY BROWN 



AUTHUR ACKERMAN 



MARGARET PEARSON 



MERLE PERLMOTTEN 



ED & JEAN WITT 



HEARING 18181 OAK WOOD 

SUITE 302 
DEARBORN, MI 48124-4092 

HEARING * 2021 MONROE 

DEARBORN, MI 48124 

HEARING 321 W. LAFAYETTE 

DETROIT, MI 48226 

HEARING 24530 WINONA 

DEARBORN, MI 4 8124 

LETTER 353 MOUNTAIN ROAD 

WILTON, CT 06897 

LETTERS 113 WASH. VALLEY RD 

MORRISTOWNSHIP, NJ07961 

LETTER 1550 BUCKS HILL ROAD 

SOUTHBURY, CT 06488 

STATEMENT 20 CHERRY AVE 

NEW ROCHELLE, NY 10801 

POST CARD 6 ELM STREET 

MIDDLETWON, NY 10940 



97 



RICHARD WRIGHT SR. 



ANN VESONDER 



BRENDA SHAFFER 



LOUIS CORSARO, M.D. 



WILLIAM C. GROTH 



POST CARD 19 FAIRLAWN AVENUE 

MIDDLETOWN, NY 10940 

LETTER 333 6 LAMOR ROAD 

HERMITAGE, PA 16148 

LETTER 212 CENTRAL STREET 

ELKINS, WV 26241 

LETTER KATONAH MED. GROUP, P.C 

111 BEDFORD ROAD 
KATONAH, NEW YORK 10536 

LETTER 6812 WALMER STREET 

OVERLAND PARK, KS 66204 



JUDITH VENTRELLA 



IRWIN VANDERHOOF 



PAULA GORNEY. 



LETTER 



LETTER 



LETTER 



82 GARS IDE AVE 
WAYNE, NJ 07470 

44 W. 4TH ST SUITE 9-190 
NEW YORK, NY SUITE 10012 

2250 W. FREELAND RD 
SAGINAW, MI 48604 



JOHN CDONNELL 
JENNIFER S. BUGBEE 

KATHLEEN M. ZISEL 

MONICA JOHNSON 

JOANNE F. DALBY 

FREDDA KRAY 

I. ELAINE MCBRAYER 



STATEMENT NO ADDRESS 

LETTER 24 W. GRAND ST 

BEREA, OHIO 44017 

LETTER 14 LINFORD LANE 

MELVILLE, NEW YORK 11747 

LETTER 824 WOODSIDE DRIVE 

SEYMOUR, WI 54165 

LETTER 14521 FISHER AVENUE NE 

PRIOR LAKE, MN 55372 

LETTER SHERIDAN ROAD 

SCARSDALE, NY 10583 

LETTER 108 BRIAN AVENUE 

BELTON, MISSOURI 64012 



MICHELLE MCBRAYER 



JO ANN LOS AD A 



EDELTRAUD A. RUSSELL 



ALBEN GOLDSTEIN, M.D. 



KIMBERLY C. KIRK 



ANN H. LATIMER 



LETTER 



LETTER 



LETTER 



LETTER 



LETTER 



LETTER 



6807 E. 157TH ST 
BELTON, MO 64012 

22-63 23RD ST 
ASTORIA, NY 11105 

4061 S. 9 MILE ROAD 
ALLEGANY, NY 14 706 

6305 CASTLE PLACE 

SUITE 2A 

FALLS CHURCH, VA 22044 

29 MIDLAND DRIVE 
DALLAS, PA 18612 

50 POUND RIDGE ROAD 
POUND RIDGE, NY 10576 



98 



MEREDITH S. FOSTER 



JOAN MCCALLUM 



ROBERT SCHHALJE 



LETTER 



LETTER 



LETTER 



RANDALL S. KRAKAUER, M.D. LETTER 



2115 GEORGETOWN BLVD. 
ANN ARBOR, MICHIGAN 48105 

P.O. BOX 3096 
OAKTON, VA 22124 

2 AUGUSTA COURT 

EDISON, NEW JERSEY 08820 

SETON HALL UNIVERSITY 
SCHOOL OF GRAD. MED. ED. 
SOUTH ORANGE, NJ 0707 9 



LORRAINE DEMATTEO 



S.M. YOUSUF ALI, M.D, 



CYNTHIA BERNART 



MARIA A. CAAMANO 



LAUREANO CAAMANO 



JANET £ THOMAS JEMEC 



LETTER 



LETTER 



LETTER 



LETTER 



LETTER 



LETTER 



33 MARGARET ROAD 
MASSAPEQUA, NY 11758 

INTERNAL MEDICINE 
515 N. RIDGEFIELD AVE 
BRIDGEPORT, CONN. 06610 

15 CAMBRIDGE ROAD 
LIVINGSTON, NJ 07039 

61 WEST EDGAR ROAD 
LINDEN, NJ 07036 

61 WEST EDGAR ROAD 
LINDEN, N.J. 07036 

1 EBONY COURT 
BROOKLYN, NY 11229 



CYNTHIA ONORATO 



ROBERT LITER 



LETTER 



LETTER 



1 WESTEMORELAND RD 
RIDGEFIELD, CT 06877 

101 BLOSSOM TER. 
WASHINGTON, ILL. 61571 



HARRY C. KING 



JANE SCHALLER, M.D. 



CARLEEN B. KEATING 



LETTER 



LETTER 



RICHARD H. SEDER, MD, LETTER 



LETTER 



406 GREAT ELM WAY 
ACTON, MA 01718 

NEW ENGLAND MED.CNTR HOSP 
750 WASHINGTON STREET 
BOSTON, MA 02111 

315 NORWOOD PARK SOUTH 
NORWOOD, MA 02062 

735 ENDFIELD WAY 
HILLSBOROUGH, CA 94010 



LAURIE EICHSTRAD 



LETTER 



7734 BISHOP ROAD 
BRIGHTON MI 48116 



BARBARA THACKER 



LISA NOLF 



PAULA WEIL 



LETTER 



LETTER 



R.J. SCRIMENTI, MD, SC LETTER 



LETTER 



P.O. BOX 332 
3350 CULLEN 
HARTLAND, MI 4 8353 

622 MADISON STREET 
HERNDON, VA 22070 

316 E. SILVER SPRING DR 
MILWAUKEE, WI 53217 

7 WEST 96 STREET I15C 
NEW YORK, NY 10025 



99 



ELLEN KNOPP 



Letter 



183 6 HANOVER STREET 
YORKTOWN HGTS, NY 10598 



LOU E. GOODING 



NAOMI HABERLI 



LETTER 



LETTER 



MCDONOUGH DISTRICT HOSP 
525 EAST GRANT STREET 
MACOMB, IL 61455 

P.O. BOX 42 
HANKINS, NY 12741 



MARILYN J. MCBRIDE 



LETTER 



4025 ASPEN HILLS DRIVE 
BETTENDORF, IOWA 52722 



IRA M. MAURER 



LETTER 



ELKIND, FLYNN & MAUREN,PC 
122 EAST 42ND STREET 
NEW YORK, NY 10168-0132 



CYNTHIA ONORATO 



LETTER 



1 WESTMORELAND ROAD 
RIDGEFIELD, CT 06877 



DAVID P. DEMAREST 



JO CECILLE DEMAREST 



CARLEEN KEATING 



BABETTE KIESEL 



LISA K. NOLF 



LETTER 



LETTER 



LETTER 



LETTER 



LETTER 



14 COOKS LANE 
KILLINGWORTH, CT 06419 

14 COOKS LANE 
KILLINGWORTH, CT 06419 

735 ENDFIELD WAY 
HILLSBOROUGH, CA 94010 

4 9 TRUESDALE LAKE DRIVE 
SOUTH SALEM, NY 10590 

622 MADISON STREET 
HERNDON, VA 22070 



DAVID THERRIAULT 



LETTER 



1169 WARNER HILL ROAD 
STRATFORD, CT 064 97 



ELAYNE DENER 



LETTER 



17 WATERBURY AVENUE 
STAMFORD, CONN 06902 



JAN WATSON 



LETTER 



10 HIDDEN MEADOW LANE 
NEW CANAAN, CT 06840 



DEBORAH A. SPERRAZZA 



LETTER 



37 BANKSVILLE ROAD 
ARMONK, NY 10504 



MICHAEL NEUDECK 



LETTER 



197 5 COX NECK ROAD 
MATTITUCK, NEW YORK 1952 



BONNIE GALAMBOS 



LETTER 



13 WILLOW AVENUE 
PISCATAWAY, NJ 08854 



IRENE MANN 



ANTHONY MAJESKI 



DR. & MRS. PAUL MOSS 



CECELIA RUBINO 



JOANN DONAHUE 



LETTER 



LETTER 



LETTER 



LETTER 



LETTER 



9 SUNSET DRIVE 
SUMMIT, NJ 07901 

18 LADWOOD DRIVE 
HOLMDEL, NJ 07733 

P.O. BOX 703 
MONTAUK, NY 11954 

93 WALNUT AVENUE 
RED BANK, NJ 07701 

34 ROSELAND AVENUE 
ROSELAND, NJ 07068 



100 



RICHARD T. LYNCH BOOKLET 

PAT HOLLAND LETTER 

WALLACE MATTHIAS LETTER 

MARYLYNN BARKLEY M.D. TESTIMONY 

JOAN MCCALLUM TESTIMONY 

LADONNA WICKLUND TESTIMONY 

REBECCA HUBER RN TESTIMONY 

JAYNE MULLIN TESTIMONY 

JOAN GLAUS TESTIMONY 

ALICE KURYK LETTER 

VICTORIA SEMKE LETTER 

KATHY CAVERT LETTER 

ANN HIRSCHBERG LETTER 

LYME DISEASE PETITION PETITION 

BARBARA GOLDKLANG HEARING 

MORRIS AREA LYME SUPPORT HEARING 



KENNETH LIEGNER, M.D, 



LYMENET 



ANN EBERT 



THORA GRAVES 



DIANNA K. WIGGINS 



REP. ROBERT C. SCOTT 



JOHN S. O'DONNELL 



TESTIMONY 



LETTER 



LETTER 



LETTER 



LETTER 



LETTER 



LETTER 



17 MONROE AVENUE 
STATEN ISLAND, NY 10301 

SOUTH JERSEY 

17 900 GEORGES LANE 
FORT BRAGG, CA 95437 

UNIV. OF CA DAVIS 
DAVIS, CA 95616 

P.O. BOX 3096 
OAKTON, VA 22124 

IOWA CITY, IOWA 

1278 DAY STREET 
GALESBURG, IL 61401 

NO ADDRESS 

NO ADDRESS 

11200 FIVE SPRINGS RD 
LUTHERVILLE, MD 21093 

1203 DRUMBARTON CT 
COLUMBUS, OHIO 43235 

NO ADDRESS 

7 64 4 MAIN STREET 

OLMSTED FALLS, OHIO 4 4138 



WESTCHESTER CHILDREN LYME 
DISEASE SUP. GROUP INC. 
P.O. BOX 495 
ARMONK, NY 10504 

P.O. BOX 1483 
MORRISTOWN, NJ 07960 

8 BARNARD ROAD 
ARMONK, N.Y. 10504 

1050 LAWRENCE AVENUE 
WESTFIELD, NJ 07090-3721 

20 BEACON DRIVE 
HOWELL, NJ 07731 

P.O. BOX 1734 
SONOMA, CA 954 7 6 

107 6 BAUMOCK BURN DRIVE 
W. WORTHINGTON, OH 104 3234 

501 CANNON OFFICE BLDG 
WASH., DC 20515-4603 

1738 26TH AVE EAST 
SEATTLE, WA 98112 



101 



HELEN E BENSON 



LETTER 



19 MICHAELS LANE 
CROTON HUDSON, NY 10520 



BARBARA GOLDKLANG 

FREDDA KRAY 

PJ LUCIE 
KELLY PERTAK 
MINDY SILBERLICHT 

SARAH J. P INCUS 

SEHYL S. DEVER 

ANITA GLICK 

ANGELA M. THOMPSON 
PATRICIA BERGER 
LINDA BOLSTER 
PATRICIA WALSH 
JO MCCALLUM 

V.V. TARPINIAN, MD 
LYNN LATCHFORD 



JOEL BROUDE 



MARY STUDER 



TIMOTHY WEISERT 



JACQUELINE BONANNO 



JOHN COUGHLAH 



LETTER 35 OLD FARM ROAD 

PLEASANTVILL, NY 10570 

LETTER SHERIDAN ROAD 

SCARSDALE, NY 10583 

TESTIMONY YORKTOWN HEIGHTS, NY 

REPORT WHITE PLAINS, NEW YORK 

LETTER 4 LANDAU LANE 

SPRING VALLEY, NY 10977 

LETTER 427 WHITEHALL ROAD 

ALBANY, NY 12208 

LETTER 3320 THOMPSON CIRCLE 

ROCKY RIVER, OHIO 44116 

LETTER 24 67 RTE 10 

BUILDING 21-APT 8-B 
MORRIS PLAINS, NJ 07950 

LETTER 1131 CONCORD TERRACE 

* OWENSBORO, KENTUCKY 4 2303 

LETTER 10 CONDIT ROAD 

MOUNTAIN LAKES, NJ 07046 

LETTER 7 9 CLINTON AVENUE 

WESTWOOD, NJ 07675 

LETTER 98 GARDEN ROAD 

SCARSDALE, NY 

LETTER LYME DIS. INFO. CENTER 

P.O. BOX 3096 
OAKTON, VA 22124 

LETTER 500 UNION BLVD. 

TOTOWA, NJ 07512 

LETTER P.O. BOX 7 58 

MORRISTOWN, NJ 07 963 

LETTER 64 2 9 GLIDDEN STREET 

SAN DIEGO, CA 92111-6916 

LETTER 805 FIRST ST. W ID 

SONOMA, CA 95476 

LETTER 27 BARTON PL SE 

HEBRON, OHIO 43055 

LETTER 38 WOODLAND ROAD 

BAYVILLE, NJ 08721 

LETTER 352 CURRIER ROAD 

EAST FALMOUTH, MA 02536 



CLARE MOUISSEY AHERN 



LETTER 



BOSTON, MASSACHUSETTS 



102 



DR. JOHN DRULLE 



JUDY LEBENSBERG 



ANTONETTA MACHOTKA 



MARY HORTZ 



LAURA M. FLYNN 



LETTER 



LETTER 



LETTER 



LOU ANNE NORTON -WHENER LETTER 



LETTER 



LETTER 



43 CABLE DRIVE 

LITTLE HARBOR, NJ 08087 

104 HERITAGE BLVD 
PRINCETON, NJ 08540 

1226 RIPPLE AVENUE 
MANAHAWKIN, NJ 08050 

2515 TWIN LAKES DRIVE 
MANASQUAN, NJ 08736 

RR1 BOX 382A 
ELHERFIELD, IND 47613 

2 VAIL ROAD 
LANDING, NJ 07850 



DIANE L. SMITH 



SUSAN M. PRICE 



LETTER 



LETTER 



1900 N. HUGHES RD 
HOWELL, MI 48843 

205 PINECONE LANE 
SPRINGBORO, OHIO 45066 



JO CECILLE DEMAREST 



LETTER 



14 COOKS LANE 
KILLINGWORTH, CT 06419 



CARL BLOCK 



KATHRYN A. ARY 



GAWAINE BANKS 



LETTER 



STATEMENT 



LETTER 



775 EAST BAY AVENUE 
MANAHAWKIN, NJ 08050 

609 E. KINGSPORT 
BROKEN ARROW, OK 74011 

1127 ROLLINGSHILLS DR. 
CINCINNATI, OHIO 45255 



CHERYL BROCK 



CYNTHIA BERNART 



LETTER 



LETTER 



10 WALNUT AVENUE 
LARCHMONT, NY 10538 

15 CAMBRIDGE ROAD 
LIVINGSTON, N.J. 07039 



RUTH STROUP 



LAUREANO CAAMANO 



LETTER 



LETTER 



15 CAMBRIDGE ROAD 
LIVINGSTON, NJ 07039 

61 W. EDGAR ROAD 
LINDEN, N.J. 07036 



HILARY MCDONALD 



LETTER 



29336 TARGHEE LANE 
EVERGREEN, COLORADO 80439 



SARAH A. BAUER 



ALEC S. COSTERUS 



DEBORAH AMDUR, MD 



LESLEY ANN FEIN MD 



KAREN DUPREE - 



LETTER 



LETTER 



LETTER 



LETTER 



LETTER 



706 COLGATE AVENUE 
LANOKA HARBOR, NJ 08734 

23339 SHINGLE CREEK ROAD 
GOLDEN, COLORADO 80401 

101 CEDAR LANE, SUITE 202 
TEANECK, NEW JERSEY 07666 

693 BLOOMFIELD AVENUE 
W. CALDWELL, NJ 07006 

R D 2 BOX 130 
CLARION, PA 16214 



103 



MICHELLE H. MCBRAYER LETTER 

PETER AGNETTI LETTER 

THOMAS F. SMITH LETTER 

FAY IVEY LETTER 

SALLIE F. TIMPONE LETTER 

PETER C. TOREN, M.D. LETTER 

MEREDITH S. FOSTER LETTER 



6807 E. 157TH STREET 
BELTON, MO 64012 

62-15 53 AVENUE 
MASPETH, NEW YORK 11378 

BOX 1001 THORNHORST RD 
GOULDSBORO, PA 18424 

107 PECAN STREET 
ROME, GA 30161 

HASBROUCK HEIGHTS, NJ 

5735 RIDGE AVE. SUITE 207 
PHILADELPHIA, PA 19128 

2115 GEORGETOWN BLVD 
ANN ARBOR, MI 48105 



PAT SMITH 

LAURA G. BUDD 
MARGARET GRAYSON 

MARY MILO 

ANTHONY TEDEACHI JR 

SAMUEL ALOISI 

JUDITH K. COLEMAN 

CHARLIE ACKERSON 

KAREN ANGOTTI 

EARL CRAWFORD 

JOAN GLAUS 

DOREEN A. RINALDO 

ELLEN ANDERSON, RN 

ROBERT ANDERSON, PHD 
KIMBERLY M. BAKAE 
DEBORA A SCATUCCIO 



LETTER 

LETTER 
LETTER 

LETTER 

LETTER 

LETTER 

LETTER 

LETTER 

LETTER 

LETTER 

LETTER 

LETTER 

LETTER 

LETTER 
LETTER 
LETTER 



5019 MEGILL RD 
FARMINGDALE, NJ 07727 

MORRISTOWN, NJ 07 960 

28 SANDFORD STREET 
TUCKERTON, N. J. 08087 

BANKS FARM ROAD 
BEDFORD, NY 10506 

1273 NORTH AVE APT 2-3B 
NEW ROCHELLE, NY 10804 

85 ROSE AVENUE 
HARRISON, N.Y. 

158 RABBIT HILL RD 
NEW PRESTON, CT 06777 

109 N. 9TH STREET 
OLEAN, N.Y. 14760 

909 ROCKY HILL CT 
CORDOVA, TN 38018 

598 BREWERS BRIDGE ROAD 
JACKSON, NJ 08527 

505 EAST 22ND AVE 
COAL VALLEY, IL 61240 

333 LINDEN ROAD 
ROSELLE, NJ 07203 

17 STAFFORD DRIVE 
HUNTINGTON ST, NY 11746 

NEW YORK 

PENNSYLVANIA 

3 COVE COURT 
HOWELL, NJ 07731 



LORRAINE METHANY 

LISA NOLF 

MARTHA KRAMER 

BRUCE PARKER 

DERRICK DESILVA 

HENRY HOLT 

LINDA CHISHOLM 

LAURA LEE AMES 

CAROL STOLOW 

WILLIAM HYATT 

STEPHEN J. NOSTROM 

JOHN SALMON 
D.GLEN DOYLE 

FRED LAWSON 

PATRICIA ANN THOMAS 

REGINA LESLIE 

SUSAN CARLSEN 
KATHY FALCON 10 

JOHN CALLAHAN 

PAMELA LAMPE 

KAREN LEWIS 

JANICE I BEERS 



104 

LETTER 

LETTER 

LETTER 

LETTER 

LETTER 

LETTER 

LETTER 

LETTER 

LETTER 

LETTER 

LETTER 

LETTER 
LETTER 

LETTER 

LETTER 

LETTER 

LETTER 
LETTER 

LETTER 

LETTER 

LETTER 

LETTER 



11224 HWY A12 
MONTAGUE, LA 96064 

P.O. BOX 1895 

HERNDON, VA 22070-1805 

182 6 HEMLOCK FARM 
HAWLEY, PA 18428 

778 RUE CENTER CT 
CINCINNATI, OH 45245 

750 AMBOY AVENUE 
EDISON, NJ 08837 

115 W 18TH ST 

NEW YORK, NY 10011 

95 PORTVILLE ROAD 
PROTVILL, NY 14770 

325 FRESNO STREET 
COALINGA, CA 93210 

4 3 WINTON RD 
E.BRUNSWICK, NJ 08816 

637 PROSPECT AVENUE 
PINE BEACH, NJ 08741 

P.O. BOX 4 96 
MATTITUCK, NY 11952 

MADISON, NEW JERSEY 07940 

153 CARTER ROAD 
PRINCETON, NJ 08540 

5029 EL DESTINO DR. 
LEESBURG, FL 34748 

P.O. BOX 560248 
ROCKLEDGE, FL 32956-0248 

33 MADISONVILLE ROAD 
BASKING RIDGE, NJ 07920 

LONG ISLAND, NY 

12 TIMBERWOLF DRIVE 
YARDVILL, NJ 08620 

540 WEST FARMS ROAD 
HOWELL, N. J. 07731 

576 SMITH DRIVE 

PT. PLEASANT, NJ 087 4 2 

P.O. BOX 107 6 
DRYDEN, NY 13053 

268 N. DIAMOND MILL ROAD 
CLAYTON, OHIO 4 5315 



LESLIE A. LEVINE 



LETTER 



660 WOODBURY RD 
SYOSSET, NY 117 91 



KAREN FORDYCE 



SUSAN A. COMSTOCK 



KEN FORDYCE 



105 

LETTER 
LETTER 
LETTER 



15 BATES ROAD 
JACKSON, NJ 08527 

14 BLANCHE DRIVE 
NEW EGYPT, NJ 08533 

STATE OF NEW JERSEY 
TRENTON, NJ 08625 



WENDY P. FEAGA 



LETTER 



13151 TRAIDELPHIA RD 
ELLICOTT CITY, MD 21042 



RICHARD TEGNANDER 



ANN SHORE 



BARBARA A PET ITT 



LETTER 



LETTER 



LETTER 



59 SOBOR AVE 

VALLEY STREAM, N.Y 11580 

11226 HWY A-12 
MONTAGUE, CA 

11 JARRETT COURT 
PRINCETON, JCT., NJ 



SUSAN H. LISS 



CHARLOTTE GALELLA 



LETTER 



LETTER 



ANHAROCK DRIVE 
SOMERS, N.Y. 10589 

3118 W. HURLEYPOND RD 
WALL, N.J. 07719 



KATHLEEN WELLS 



LETTER 



289 SQUANKUM RD 
FARMINGDALE, N.J. 07727 



LESLIE A. LEVINE 



PAT SMITH 



DIANE D. BETZ 



LETTER 



LETTER 



LETTER 



660 WOODBURY ROAD 
SYOSSET, NY 11791 

5019 MEGILL ROAD 
FARMINGDALE, NJ 07727 

NO ADDRESS 



DAN SAWYER 



LETTER 



BARBARA W. FRANZEN, MD LETTER 



VICTORIA FEIS 



LINDA FEIS 



IMMANUEL KOHN 



DENISE V. LANG 



MARY HALLSTEN 



SUSAN LARCHUK 



LETTER 



LETTER 



LETTER 



LETTER 



LETTER 



LETTER 



3032 SANDY HOOK DR 
ROSEVILLE, MN 55113 

P.O. BOX 810 
COBB, CA 95426 

34 6 HAYES AVE 
BAYSVILLE, NJ 08721 

34 6 HAYES AVE 
BAYSVILLE, NJ 08721 

34 PURITAN CT 
PRINCETON, NJ 08540 

25 MINISINK ROAD 

CONVENT STATION, NJ 07961 

3864 S CTY RD 
MAPLE, WI 54854 

216 2ND AVE 

HIGHLAND PARK, NJ 08904 





106 


SANDRA K. BERENBAUM 


LETTER 


RICHARD CARLSEN 


LETTER 


SUSAN BECKLEY 


LETTER 


DIANE BENACK-MULLIN 


LETTER 


LOIS A. DOUGERT 


LETTER 


KEITH A DAMA 


LETTER 


LYNN TESSIER 


LETTER 


BURLISSA WARD-QUINN 


LETTER 


SUZANNE FESTA 


LETTER 


SUSAN E. DICK M.D. 


LETTER 


AMANDA COLEMAN 


LETTER 


DJ FRANZMATHES 


LETTER 


SUE FRANZMATHES 


LETTER 


PAMELA HOFFMAN 


LETTER 


JUDY J. SUJKO 


LETTER 


ROSALEA KELLEY 


LETTER 


DAVID £ SANDRA 


LETTER 



TISH MAKAI LETTER 

DEBORAH PHILIPS-ABBOTT LETTER 



TOM CLEMETSON 



SUSAN M. PRICE 



LETTER 



LETTER 



2 SUMMIT CT SUITE 202 
FISHKILL, NY 12524 

BOX 332 

LONG ISLAND, NY 11973 

NO ADDRESS (FAXED) 

287 ARNEYS MT . ROAD 
PEMBERTON, NJ 08068 

254 6 N. PACER LN 
COCOA, FL 32926 

5 MOHINGSON COURT 
HOLMDEL, NJ 07733 

ROUTE 1 BOX 39F 
COLBERT, GA 30628 

RD 4 BOX 4 57 
CENTREVILLE, MD 21617 

RIDGEFIELD, CT 

230 NEPTUNE BLVD STE 202 
NEPTUNE, NJ 07753 

THE BREARLEY SCHOOL 
NY, NY 

26-10 N. BURGEE DR 
TUCKERTON, NJ 08087 

988 W BAY AVE 
BARNEGAT, NJ 08005 

BRENTWOOD, CA 9004 9 

3514 HICKORY GROVE RD 
HORSEHEADS, NY 14845 

9805 NW VIEW COVE DR. 
KANSAS CITY, MO 64152 

124 W. CHIPPENS HILLS RD 
BURLINGTON, CONN. 06013 

MORRISTOWN HOSPITAL 

3661 HERSHEY ROAD 
ERIE, PA 165-4752 

4 903 RITCHIE-MARLBORO 
UPPER MARLBORO, MD 20772 

205 PINECONE LANE 
SPRINGBORO, OHIO 45066 



TERESSA MCVEIGH 



YOLANDA & JOE WOLFEL 



ELLEN M. CLEMETSON 



LETTER 



LETTER 



LETTER 



120 SPRINGWOOD DR 
FREDERICKSBURG, VA 22401 

4 85 WOLFEL AVE 

SAINT MARYS, PA 15857 

839 LAUREL BLVD 

LANOKA HARBOR, NJ 08734 



107 



VALERIE K. NOVAK, MD 



RONDA L. BARTHOLOMEW 



CHERYL BROCK 



PATRICIA DUNCAN 



MRS. IMMANUEL KOHN 



LETTER 



LETTER 



LETTER 



LETTER 



LETTER 



1630 TULANE ROAD 
CLAREMONT, CA 91711 

698 6 EAST STATE STREET 
SHARON, PA 1614 6 

10 WALNUT AVENUE 
LARCHMONT, NY 10538 

315 OAK RIDGE DR N 
HUDSON, WI 54016 

34 PURITAN CT 
PRINCETON, NJ 08540 



ANNETTE JERIGAN LETTER 

PAT SMALLEY LETTER 

RUCHANA WHITE LETTER 

JOHN BLEIWEISS, M.D. TESTIMONY 

MARION S, DICK SAFFORD LETTER 



55 NEEDLE BLVD #80 
MERRITT ISLAND, FL 32 953 

RD 1 BOX 84 COOKINGHAM DR 
STAATSBURG, NY 12580 

60 TRQNQUILITY ROAD 
SUFFERN, NY 10901 

NEW JERSEY FAXED 

RTE 82 

LA GRANGEVILLE, NY 12540 



ROBERTO R. BORTON, JR. 



LETTER 



1 GARRET PLACE 16 F 
BRONXVILLE, NY 10708 



MRS JOHN MORTON, III 



LETTER 



1000 WESTONER ROAD 
KANSAS CITY, MISSOURI 



SETH U THALER, MD LETTER 

SANDY MELLION LETTER 

KAREN G. LEWIS LETTER 

FRANCES GURGRANDO LETTER 

LOU ELLEN GOODING LETTER 

WILLIAM SCHULTZ LETTER 

NAOMI HABERLI LETTER 

MARGARET REDARD LETTER 

MRS. GLORIA MILK LETTER 

MRS. CANDIA SHIFRIN LETTER 



14 SCOTCHTOWN AVENUE 
GOSHEN, NY 10924 

7 HICKORY DR 

NEW CITY, NY 10956 

11 GREYSTONE DRIVE 
DRYDEN, NY 13053 

NEW JERSEY 

BOX 568 

ROSEVILLE, IL 61473 

P.O. BOX 65 
CALLICOON, NY 12723 

P.O. BOX 42 
HANKINS, NY 12741 

RIDGE RD POB 118 
HANKINS, NY 12741 

P.O. BOX 124 

LONG EDDY, NY 12760 

P.O. BOX 145 
HANKINS, NY 12741 



108 



DEBORAH FORSBLOM 



GLORIA BAKER 



MRS. E. RYAN 



SUSAN C. BRENNAN, MD 



CARL BLOCK 



PHYLLIS MERVINE 



WILLIAM C. GROTH 



LETTER 



LETTER 



LETTER 



LETTER 



LETTER 



LETTER 



LETTER 



PO BOX 12 9 
HANKINS, NY 12741 

P.O. BOX 185 
HANKINS, NY 12741 

P.O. BOX 127 
HANKINS, NY 12741 

2200 SAW MILL RIVER RD 
YORKTOWN HEIGHTS, NY 10598 

TOWNSHIP OF STAFFORD 
NEW JERSEY 

P.O. BOX 1423 
UKIAH, CA 95482 

6812 WALMER STREET 
OVERLAND PARK, KS 66204 



MCLAUREN 



LETTER 



WILLIAM HARRYMAN III, MD LETTER 



•JON V, POWELL 



REP . TOBY ROTH 



LETTER 



LETTER 



27291 RIDGE LAKE CT 
BONITA SPRINGS, FL 33923 

RR 7, BOX 475 

MARION, IL 62959-9807 

17710 INDIAN HEAD HWY 
ACCOKEEK, MD 20607 

2234 RAYBURN BUILDING 
WASH., DC 20515 



ANN COLUMBA 



HENRY MAGIERSKI 



ANNETTE JERIGAN 



PATRICIA ANN THOMAS 



LETTER 



LETTER 



LETTER 



LETTER 



16 THE FAIRWAY 

UPPER MONTCLAIR, NJ 07043 

17 SHIP DRIVE 

MYSTIC ISLAND, NJ 08087 

55 NEEDLE BLVD., 180 
MERRITT ISLAND, FL 32 953 

P.O. BOX 560248 
ROCKLEDGE, FL 32956 



STEPHEN L. MCMAHON 



LETTER 



1628 DUBAC ROAD 

WALL TOWNSHIP, NJ 07719 



MARGARET OREFICE 



LETTER 



29 MONROE STREET 

W. LONG BRANCH, NJ 07 7 64 



ALBERT D' ANTON IO 



BEVERLY DYER 



LETTER 



LETTER 



138 METCALF ROAD 
TOLLAND, CT 06084 

1863 KALORAMA ROAD, N.W. 
WASH., DC 20009 



NORMAN R. JOHNSON 



LETTER 



3487 S. LINDEN RD 
FLINT, MI 48507 



DEBBIE SIRACUSANO 



LETTER 



25-02 ASTORIA BLVD 
ASTORIA, NY 11102 



AMY & BARRY EISENBERG PHD LETTER 



11 SANDALWOOD DRIVE 

E. BRUNSWICK, NJ 08816 



109 



MOLLY BENNETT 



KEITH A DAMA 



LOU PRICE 



STMT 



LETTER 



LETTER 



71 MARTIN STREET 141 
CAMBRIDGE, MA 02138 

5 MOHINGSON CT 
HOLMDEL, NJ 07733 

HENDERSON, KY 



MARIANNE FISCHER 



ROBERT A. DEMMY 



MARGARET LEBENSBERG 



SARI L. GOLDBERG 



MARY LOU LEIST 



CAROL KILGANNON 



JANICE I BEERS, JD 



THOMAS E. MARA 



JOSEPH FISHER 



KAREN S. JACOBSEN 



DOREEN A. RINALDO 



PAT SMITH 



ANN COLUMBO 



SUSAN E. DICK, MD 



MARLA WERNICKI 



SUSAN E. DEMMY 



REGINA LESLIE 



KATHLEEN WELLS 



KATHY FALOONIO 



DIANE BENACK-MULLIN 



LETTER 

LETTER 

LETTER 

LETTER 
LETTER 

LETTER 
LETTER 
LETTER 
LETTER 
LETTER 
LETTER 
LETTER 
LETTER 
LETTER 
LETTER 
LETTER 
LETTER 
LETTER 
LETTER 
LETTER 



7 EAST 14TH ST #1029 
NY, NY 10003 

715H ORION PARK 
MT VIEW, CA 94043 

181 VAN WINKLE LANE 
MAHWAH, NJ 07430 

6 MACLEISH DR 
MORGANVILLE, NJ 07751 

12 CEDAR ROAD 

WADING RIVER, NY 11792 

5 SHAY LANE 
x BRICK, NJ 08723 

2 68 N. DIAMOND MILL RD 
CLAYTON, OHIO 4 5315 

506 HAMPTON HILL 
FRANKLIN LAKES, NJ 07417 

30 GRIGGS ROAD 
BROOKLINE, MA 02146 

675 N. CORTEZ STREET 
SALT LAKE CITY, UT 84103 

333 LINDEN ROAD 
ROSELLE, NJ 07203 

5019 MEAILL ROAD 
FARMINGDALE, NJ 07727 

16 THE FAIRWAY 

UPPER MONTCLAIR, NJ 07043 

230 NEPTUNE BLVD 
NEPTUNE, NJ 07753 

40 TARRAGON COURT 
W.DEPTFORD, NJ 08086 

715-H ORION PARK 
MT. VIEW, CA 94043 

33 MRDISONVILLE ROAD 
BASKING RIDGE, NJ 07920 

289 SQUANKUM RD 
FARMINGDALE, NJ 07727 

12 TIMBERWOLF DRIVE 
YARDVILLE, NJ 08820 

287 ARNEYS MT. RD 
PEMBERTON, NJ 08068 



110 



D. GLEN DOYLE 

MARGARET M. KOHN 
MRS. IMMANUEL KOHN 

LINDA FEIS 

SUSIE MERRILL 
DAVID L COATES 

SHIRLEY MOORE 

ANN FRANK 

MARION PARKINSON 
JOHN O'DONNELL 

IRWIN VANDERHOOF 

PAUL E. LAVOIE, MD 

MARIAN P. MCLAURIN 



LETTER 

LETTER 
LETTER 

LETTER 

LETTER 
LETTER 

LETTER 

LETTER 

LETTER 
LETTER 

LETTER 

LETTER 

LETTER 



153 CARTER ROAD 
PRINCETON, NJ 08540 

8 DEAN COURT 
CRNABURY, NJ 08512 

34 PURTIAN CT 
PRINCETON, NJ 08540 

34 6 HAYES AVE 
BAYNIVILLE, NJ 08721 

NO ADDRESS 

RD 13 89-B 

SUGAR GROVE, PA 16350 

RD II BOX 37 

NEW EGYPT, NJ 08533 

608 HOMESTEAD ROAD 
BRIELLE, NJ 08730 

R2,EWLLFLEET MA 02667 

1738 2 6TH AVENUE EAST 
SEATTLE, WA 98112 

44 W. 4TH ST SUITE 9-190 
NY, NY 10012 

1700 CAILFORNIA ST 

SAN FRANCISCO, CA 94115 

27291 RIDGE LAKE COURT 
BONITA SPRINGS, FL 33923 



FRANK C. DEMAREST 



LLOYD MILLER, DVM 



LETTER 



LETTER 



VIRGINIA Ti BRICKER PH.D LETTER 



BEVERLY SPITZ 



AUDREY GOLDING, MD 



PHIL WATSKY, MD 



CYNTHIA A. RETOTAR 



ANN E. VESONDER 



RAYMOND WOLFEL 



MANMOHAN BRYANT, MD 



LETTER 



LETTER 



LETTER 



LETTER 



LETTER 



LETTER 



LETTER 



315 E. RIDGE ROAD 
MIDDLETOWN, CT 06457 

380 N. GREENBUSH RD 
TROY, NY 12180 

13 GUINEVERE CT 
BALTIMORE, MD 21237 

68 GREEN KNOLLS DR 
WAYNE, NJ 07470 

1151 BUCKNER BLVD STE 101 
DALLAS, TEXAS 75218 

61 BRADLEY STREET 
BRISTOL, CT 06010 

778 LONG HILL ROAD 
GILLETTE, NJ 07933 

333 6 LAMOR ROAD 
HERMITAGE, PA 16148 

485 WOLFEL AVENUE 
ST. MAREYS, PA 15857 

56 S. MAIN ST., STE A 
STOCKTON, NJ 08559 



Ill 



MARY INMAN 



JEANETTE GIBERSON 



JENNIFER KRASINSKI 



DIANNA R. WIGGINS 



LYME DIS INFO CNTR 



WALLACE OBRIEN 



LUCY GEORGE 



MONICA JOHNSON 



RUTH ELDER 



CINDY JONES 



LETTER 



LETTER 



LETTER 



LETTER 



LETTER 



LETTER 



LETTER 



LETTER 



LETTER 



LETTER 



425 MAIN ST 

WEST CREEK, NJ 08092 

434 PFEIFFER AVE 
CEDAR RUN, NJ 08092 

300 MORRIS AVENUE 
MOUNTAIN LAKE, NJ 07046 

107 6 BAUMOCK BURN DRIVE 
W WORTHINGTON, OHIO 43235 

P.O. BOX 3096 
OAKTON, VA 22124 

2703 HIGHCLIFF DR 
TORRANCE CA 90505 

100 BEECH DR 
FRANKLIN, PA 16323 

824 WOODSIDE DRIVE 
SEYMOUR, WI 54165 

164 DYCKMAN PLACE 
BASKING RIDGE, NJ 07920 

120 FOX SHANNON PL 

ST. CLAIRSVILL, OH 43950 



JANET JEMEC LPN 



LETTER 



NETWORK OF NJ 



ELAINE TAYLOR 



LETTER 



350 SIXTH STREET 
ATCO, NJ 08004 



SEN. RUSSEL FEINGOLD 



LETTER 



502 HART SENATE OFC BLG 



ELSIE ANDERSON 



ANNE D. BROWN 



GEORGE E. YOUNG 



LETTER 



LETTER 



LETTER 



P.O. BOX 1483 
MORRISTOWN, NJ 07960 

P.O. BOX 310 
COMO, MS 38619 

2 CANAL STREET 
CHATS WORTH, NJ 08019 



FRED S KAREN STECKLER 

ANITA L. SMITH 

JANET M. BOOMER 
LAURIE TAYLOR 

LONNIE SOLIN 

LINDA GOFFINET 



MARGARET KANTES 



LETTER 

LETTER 

LETTER 
LETTER 

LETTER 

LETTER 

LETTER 



v R.R. 1, BOX 304 

MT. CARMEL, IL 62863 

7720 BISHOP RD 
BRIGHTON, MI 48116 

2631 HIGH MEADOWS 

9365 WHITE PINE CT 
LINDEN, MI 48451 

230 GATH ROAD 
SCANSDALE, NY 10583 

801 ALLARDICE WAY 
STANFORD, CA 94 305 

1404 DRUM HILL ROAD 
MARTINSVILLE, NJ 08836 



142 



ELISSA VIGLIANCO 

JENNIFER REISZ 

PHYLLIS MERVINE 

DONALD M. THARP 
ROSETTA SI LAV 

MILDRED BUGBEE 



LETTER 

LETTER 

LETTER 

LETTER 
LETTER 

LETTER 



548 PEREGRINE DRIVE 
INDIALANTIC 32903 

4130 YEWELLS LNDG WEST 
O'BORO, KY 42303 

P.O. BOX 1423 
UKIAH, CA 95482 

MT CARMEL, ILLINOIS 

RDI BOX 358 
WINDSOR, PA 17366 

7638 MIDDLE RIDGE 
MADISON, OHIO 44057 



MARY ELLEN MONAHAN 
PAT SCHWALJE 
SUSAN M. PRICE 

RUTH NOLT 

GAYLE SINGER 

MARYLOU EISENHARDT 

RALPH DEVER 

DIANE HASKELL 
EILEEN WRIGHT 

ALICE KURYK 

JOSEPH FISHER 

JOHN BICHARD 

VICKIE BOYER 

FREDDA KRAY 

GREG EVANS 

JENNIFER KRASINSKI 

LINDA BOLSTER 



LETTER 
LETTER 
LETTER 

LETTER 

LETTER 

LETTER 

LETTER 

LETTER 
LETTER 

LETTER 

LETTER 

LETTER 

LETTER 

LETTER 

LETTER 

LETTER 

LETTER 



38 OLD MIDDLETOWN RD 
ROCKAWAY, NJ 07866 

2 AUGUSTA COURT 
EDISON, NJ 08820 

205 PINECONE LANE 
SPRINGBORO, OHIO 45066 

116 LOCUST STREET 
LEOLA, PA 17540 

THIRD POND LANE 
BEDFORD, NY 

R 12 BOX 407 
CAIRO, NY 12413 

3320 THOMSON CIRCLE 
ROCKY RIVER, OH 44116 

NEW JERSEY 

19 FAIRLAWN AVE 
MIDDLETOWN, NY 10940 

11200 FIVE SPRINGS RD 
LUTHERVILLE, MD 21093 

384 MERROW ROAD 
TOLLAND, CT 06084 

124 2 CATHCART BLVD 
SARNIA, ONTARIO CAN 

911 MOHILL PLACE 
PISCATAWAY, NJ 08854 

SHERIDAN ROAD 
SCARSDALE, NY 10583 

1017 4TH AVENUE 
IOWA CITY, IA 52240 

300 MORRIS AVE 
MOUNTAIN LAKE, NJ 0704 6 

7 9 CLINTON AVE 
WESTWOOD, NJ 07 675 



113 

V 



JOYCE O THOMPSON 

ELLEN LESTER 

JOHN D. SCOTT 
IRENE MANN 

ANNETTE DOCTOR I CK 



LETTER 

LETTER 

LETTER 
LETTER 

LETTER 



ILENE L. MCCAULLEY JD LETTER 



SHARON M. DAVIS 



TERRY DIFIORE 



BARBARA J WEGMANN 



ROGER A. DOYLE 



S. CHANDRA SWAMI, MD 



LINDA FLORY 



LETTER 



LETTER 



LETTER 



LETTER 



LETTER 



LETTER 



JOHN R. LA MONTAGNE PH.D LETTER 

JAMES M. HUGHES, M.D. TESTIMONY 

KAREN V. FORSCHNER TESTIMONY 

CLARE AHERN . TESTIMONY 

FREDERICK A. MURPHY LETTER 

PAT SMITH TESTIMONY 

NITA M. LOWEY TESTIMONY 

GEORGE HOCHBRUECKNER TESTIMONY 



12166 RIVERGROVE ST 
MOORPARK, CA 93021 

P.O. BOX 151 
GUALALA, CA 954 45 

365 ST DAVID ST. S. f 
FERGUS, ONTARIO N1M 2L7 
9 SUNSET DRIVE 
SUMMIT, NJ 07901 

RD 12 BOX 153 

MONONGAHEIA, PA 15063 

184 5 S. DOBSON RD STE 213 
MESA, ARIZONA 85202 

1000 S ST. RT 1741 
LEBANON, OHIO 45036 

37 VIRGINIA DRIVE 
MANHASSET, NY 11030 

537 KING GEORGE CT 
SPRINGBORO, OHIO 45066 

BOX 373 

LITCHFIELD, CT 06759 

701 N. HERMITAGE RD 
HERMITAGE, PA 16148 

9931 BUNNELL HILL RD 
CENTERVILLE, OHIO 4 54 58 

DIVISION OF MICROBIOLOGY 
& INFECTIOUS DISEASES 

DEPT. OF HHS 
ATLANTA, GA 30333 

TOLLAND, CT 

58 SHERWOOD STREET 
VALHALLLA, NY 10595 

UNIV. OF CA. 

DAVIS, CA 95616-8734 

5019 MEGILL ROAD 
FARMINGDALE, NJ 07727 

CONGRESS OF THE US 
18TH DISTRICT, NY 



LINDA AIDINGER 



BEVERLY G. DYER 



ANN EBERT 



TESTIMONY 



TESTIMONY 



TESTIMONY 



430 SIMPSON PLACE 
PEEKSKILL, NY 10566 

1863 KALORAMA RD 
WASHINGTON, D.C 

20 BEACON DRIVE 
HOWELL, NJ 07731 



MARYLOU EISENHARDT 



114 



TESTIMONY 



BOSTON PUBLIC LIBRARY 



3 9999 05982 546 1 



ALBANY, NY 



MICHELE ANIELLO, R.N. STATEMENT 



JANICE BEERS 

J.J. BURRASCANO MD 

EVELYN CONKLIN 

KEITH DAMA 

WILLIAM J. DIDONATO 

KAREN FORDYCE 

MARC GABRIEL 

BARBARA GOLDKLANG 
JUDI HASON 

RAY HERNANDEZ 

MARTHA KRAMER 

CAROL LAYMON 

MARYLOU EISENHARDT 

HILARY MCDONALD 

MICHAEL B. ARNOLD 



LORI B. TUCKER, M.D. 



STATEMENT 

STATEMENT 

STATEMENT 

STATEMENT 

STATEMENT 

STATEMENT 

STATEMENT 

STATEMENT 
STATEMENT 

STATEMENT 

STATEMENT 

STATEMENT 

STATEMENT 

STATEMENT 

STATEMENT 



LAURIE C. MILLER, M.D. LETTER 



LETTER 



MAR ISA KLEIN-GITELMAN, MD LETTER 



DEBORAH ROTHMAN, M.D. 



LETTER 



JAMES J. NOCTON, M.D. LETTER 



BRADLEY BLOOM, M.D. 



LETTER 



232 5 LOSEE CT. 
MERRICK, NY 11566 

268 N. DIAMOND MILL 
CLAYTON, OHIO 43315 

139 SPRING ROAD 

EAST HAMPTON, NY 11937 

311 UNION AVENUE 
PEEKSKILL, NY 10566 

5 MOHINGSON CT . 
HOLMDEL, NJ 07733 

442 5TH STREET 
ATCO, NJ 08004 

15 BATES RD 
JACKSON, NJ 08527 

1050 LAWRENCE AVENUE 
WESTFIELD, NJ 07090 



34 GILDARE DRIVE 

E. NORTHPORT, NY 11731 

101 W. MAIN STREET 
CLINTON, NJ 08809 

NEBSOX LANE 
GARRISON, NY 10524 

604 4TH AVENUE 

E. NOTHPORT, NY 11731 

20 BEACON DRIVE 
HOWELL, NJ 07731 

29336 TARGHEE LANE 
EVERGREEN, CO. 80439 

5932 COVELANDING RDI204 
BURKE, VIRGINIA 22015 

750 WASHINGTON STREET 
BOSTON, MASS 02111 

750 WASHINGTON STREET 
BOSTON, MA 02111 

7 50 WASHINGTON STREET 
BOSTON, MA 02111 

750 WASHINGTON STREET 
BOSTON, MA 02111 

750 WASHINGTON STREET 
BOSTON, MA 02111 

750 WASHINGTON STREET 
BOSTON, MA 02111 



115 



WILLIAM A. AGGER, M.D. LETTER 



GARY P. WORMSER, M.D. 



LETTER 



ROBERT B. NADLMAN, M.D. LETTER 



JOHN NOWAKOWSKI, M.D. LETTER 



GUNDERSEN CLINIC, LTD 

LA CROSSE, WISCONSIN 54 602 

NY MEDICAL COLLEGE 
VALHALLA, NY 10595 

NY MEDICAL COLLEGE 
VALHALLA, NY 10595 

NY MEDICAL COLLEGE 
VALHALLA, NY 10595 



DURLAND FISH, PH.D, 



DANA WISEMAN, M.D. 



STEVEN W. LUGER, M.D. 



DANIEL W. RAHN, M.D. 



MICHAEL GERBER, M.D. 



LETTER 



LETTER 



ANDREW R. PACHNER, M.D. LETTER 



LETTER 



JOHN J. HALPERIN, M.D. LETTER 



EUGENE D. SHAPIRO, M.D LETTER 



LETTER 



CORNELIA M. WEYAND, M.D. LETTER 



LETTER 



NY MEDICAL COLLEGE 
VALHALLA, NY 10595 

131 NEW LONDON TURNPIKE 

SUITE 101 

GLASTONBURY, CONN. 06033 

GEORGETOWN UNIV. MED. CT. 
WASHINGTON, DC 20007 

2080 SILAS DEANE HWY 
ROCKY HILL, CT 06067 

N. SHORE UNIV. HOSPITAL 
MANHASSET, NY 11030 

333 CEDAR STREET 
NEW HAVEN, CT 06510 

MEDICAL COLLEGE GEORGIA 
AUGUSTA, GA 30912-3100 

MAYO CLINIC 
ROCHESTER, MN 55905 

UNIV. CT. SCHOOL OF MED. 
FARMINGTON, CT 06030-1515 



[Whereupon, at 12:40 p.m., the committee was adjourned.] 

O 



73-299 (120) 



ISBN 0-16-041765-1 




9 7801 60" 4 



7658 



90000